The document discusses standards for registered pharmacies, particularly regarding medicines safety. It notes key principles like ensuring standards are proportionate and allow for innovation. Specific issues are raised around supplying licensed medicines over unlicensed ones, exempting extemporaneous methadone preparation, and pharmacy manufacturing of medicines. Further discussion is needed on whether standards comply with policy, contradict law, and which body (GPhC or MHRA) leads on each issue. Patient safety is the overarching principle.
The document discusses several regulatory issues related to registered pharmacies and medicines. It summarizes discussions from an ad hoc group on: 1) clarifying that licensed medicines must follow legal requirements; 2) stating that extemporaneous methadone preparation is inconsistent with law; and 3) developing clear communication between regulatory bodies on manufacturing and supervision requirements. The group agreed professional judgement should guide supervision of 'P' category medicines and owners should decide how best to meet legal obligations.
The life sciences industry is a key contributor to the Canadian and global economies. In the pursuit of competitive advantage, participants in the pharmaceutical, biotech, medical device and diagnostic, and health-careservices sectors have seen significant growth attributed to major leaps in technology and an unprecedented demand for health-related goods and services. This growth has paralleled the expansion and imposition of more stringent regulatory requirements, improvement of market access, aggressive patent acquisition and enforcement, strategic M&A activity, and increased product liability claims and other litigation.
This report highlights insights and developments relating to a wide range of legal, business and consumer issues currently impacting the life sciences industry in Canada and abroad. These highlights were prepared by Blakes based on non-confidential information gathered in our practices, as well as through a review of publicly available information. Through
a series of articles, we examine the implications of some of the recent legal developments impacting the sector, including the Supreme Court of Canada’s decision to uphold Ontario’s ban on private-label generic drugs, the enforcement of prohibitions on pharmacy-related loyalty points in B.C., the Competition Bureau’s ongoing consideration of competition among pharmaceutical companies, and recent trends in Canadian litigation. We also discuss issues relating to the navigation of transfer-pricing rules, protecting intellectual property in the development of combination products, and obtaining financing for new product development and business expansion efforts. Supplementing our discussion of these matters are snapshots of consumer-facing and market trends, including integrated patient care and direct-to-consumer sales.
The document discusses purchasing medicines for hospitals in the UK. It summarizes the key processes and regulations around contracting with pharmaceutical suppliers to obtain medicines. These include the Pharmaceutical Price Regulation Scheme that controls drug prices for the NHS, requirements of EU directives regarding public procurement, and the types of contracts used including commitment and framework agreements. Standard purchasing groups aggregate hospital demand across geographical regions. Specialists are involved in evaluation and quality control.
Aware that in the following days the National Legislative Assembly will resume the discussion of the Pharmaceuticals Law draft, the CS seeks to heighten the debate by exposing its position with respect to sector´s competition conditions which was made public in November 2011.
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
Uniform code for pharmaceutical marketing Practices UCPMP Guidelines, Codes and Impact on Industry by DailyRounds.org (Largest network of doctors 200000+ & counting).
http://www.dailyrounds.org/blog/ucpmp-uniform-code-of-pharmaceuticals-marketing/
Celebrating Successful completion of one year
"Happy anniversary… Pharma Uptoday"
Thanks a lot to all members & Viewers.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 4 has been released with
News Uptoday
New Guidelines
Audit Findings
Regulation of the Month
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has developed a strategy to combat falsified medical products with the objective of reducing risks to patients and consumers. The strategy aims to enhance legal frameworks at the European Union and Council of Europe levels related to falsified medicines and strengthen safety features and controls for actors in the medical supply chain. It also addresses issues like internet sales of medicines and controls on active pharmaceutical ingredients.
The document discusses several regulatory issues related to registered pharmacies and medicines. It summarizes discussions from an ad hoc group on: 1) clarifying that licensed medicines must follow legal requirements; 2) stating that extemporaneous methadone preparation is inconsistent with law; and 3) developing clear communication between regulatory bodies on manufacturing and supervision requirements. The group agreed professional judgement should guide supervision of 'P' category medicines and owners should decide how best to meet legal obligations.
The life sciences industry is a key contributor to the Canadian and global economies. In the pursuit of competitive advantage, participants in the pharmaceutical, biotech, medical device and diagnostic, and health-careservices sectors have seen significant growth attributed to major leaps in technology and an unprecedented demand for health-related goods and services. This growth has paralleled the expansion and imposition of more stringent regulatory requirements, improvement of market access, aggressive patent acquisition and enforcement, strategic M&A activity, and increased product liability claims and other litigation.
This report highlights insights and developments relating to a wide range of legal, business and consumer issues currently impacting the life sciences industry in Canada and abroad. These highlights were prepared by Blakes based on non-confidential information gathered in our practices, as well as through a review of publicly available information. Through
a series of articles, we examine the implications of some of the recent legal developments impacting the sector, including the Supreme Court of Canada’s decision to uphold Ontario’s ban on private-label generic drugs, the enforcement of prohibitions on pharmacy-related loyalty points in B.C., the Competition Bureau’s ongoing consideration of competition among pharmaceutical companies, and recent trends in Canadian litigation. We also discuss issues relating to the navigation of transfer-pricing rules, protecting intellectual property in the development of combination products, and obtaining financing for new product development and business expansion efforts. Supplementing our discussion of these matters are snapshots of consumer-facing and market trends, including integrated patient care and direct-to-consumer sales.
The document discusses purchasing medicines for hospitals in the UK. It summarizes the key processes and regulations around contracting with pharmaceutical suppliers to obtain medicines. These include the Pharmaceutical Price Regulation Scheme that controls drug prices for the NHS, requirements of EU directives regarding public procurement, and the types of contracts used including commitment and framework agreements. Standard purchasing groups aggregate hospital demand across geographical regions. Specialists are involved in evaluation and quality control.
Aware that in the following days the National Legislative Assembly will resume the discussion of the Pharmaceuticals Law draft, the CS seeks to heighten the debate by exposing its position with respect to sector´s competition conditions which was made public in November 2011.
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
Uniform code for pharmaceutical marketing Practices UCPMP Guidelines, Codes and Impact on Industry by DailyRounds.org (Largest network of doctors 200000+ & counting).
http://www.dailyrounds.org/blog/ucpmp-uniform-code-of-pharmaceuticals-marketing/
Celebrating Successful completion of one year
"Happy anniversary… Pharma Uptoday"
Thanks a lot to all members & Viewers.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 4 has been released with
News Uptoday
New Guidelines
Audit Findings
Regulation of the Month
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has developed a strategy to combat falsified medical products with the objective of reducing risks to patients and consumers. The strategy aims to enhance legal frameworks at the European Union and Council of Europe levels related to falsified medicines and strengthen safety features and controls for actors in the medical supply chain. It also addresses issues like internet sales of medicines and controls on active pharmaceutical ingredients.
This document discusses drug procurement in hospitals. It defines procurement as acquiring supplies through purchases from manufacturers or distributors. The roles of the purchasing agent and pharmacist in drug procurement are described. The purchasing agent is responsible for issuing purchase orders, maintaining orders, following up on delays, and obtaining quotations. The pharmacist maintains supplier contact information, prepares specifications and forms, and receives drug shipments. Strategies for effective procurement include obtaining cost-effective drugs in the right quantities from reliable suppliers in a timely manner at the lowest possible cost. Methods of procurement include direct purchase, bids, contracts, and local purchase. Community pharmacy procurement involves selecting medicines, identifying financial position and suppliers, negotiating terms, and monitoring orders.
Presented at the 4th Global Animal Health Conference 2015 #GAHC2015 on Regulatory Convergence. Held in Dar Es Salaam, Tanzania, 24-25 June 2015.
This was presented by GALVmed consultant Gilly Cowan and discussed GALVmed's progress in following up the recommendations from the 2010 Global Animal Health Conference when African regulators asked for a harmonised registration system, mutual recognition and training for their regulators in the registration of veterinary vaccines.
GALVmed, the Global Alliance for Livestock Veterinary Medicines, works through its partners to protect livestock and improve human lives by making livestock vaccines, diagnostics & medicines accessible and affordable to the millions of those who rely on livestock.
For more information on this conference, hosted by Health For Animals (formerly IFAH), visit here: http://healthforanimals.org/global-animal-health-conference-addresses-regulatory-barriers/
To read more highlights from the conference, click here: https://twitter.com/hashtag/GAHC2015?src=hash
Current mci guidelines for pharmaceutical companies and governmentKamal Singh
The document discusses current guidelines from the Medical Council of India (MCI) and the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) regarding relationships between doctors and the pharmaceutical industry. The MCI code addresses gifts, travel, hospitality, cash/grants, medical research standards, and professional autonomy/endorsements. The UCPMP, adopted by the pharmaceutical industry from January 2015, involves general promotion approval/consistency, evidence-based product claims/comparisons, representative ethical standards, and sample authorization/quantity limits. It also regulates interactions like gifts, travel, and payments between companies and healthcare professionals.
Drug information center in a retail Drug StoreYamini Shah
This document provides an overview of drug information centers. It discusses the objectives, classification, requirements, resources, functions, and need for drug information centers. It also lists some drug information centers in India and the roles of drug information specialists. Computerized services and resources used by drug information centers are also outlined.
This issue of Pharma Uptoday provides news and updates from the pharmaceutical regulatory world. Key highlights include:
- The MHRA says it provided free expert advice to AstraZeneca on building a new UK manufacturing plant, and this help is available to all drugmakers.
- Common deficiencies cited in MHRA inspections relate to manufacturers' quality systems.
- An API plant of Dr. Reddy's in India received a US FDA Form 483 with nine observations primarily related to procedural compliance issues.
- Various regulatory agencies like Health Canada, TGA, and the Indian government announce new guidances, regulations, and plans to improve clinical trial quality standards.
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
This document provides a summary of news and regulatory information related to the pharmaceutical industry. Key points include:
- The FDA released its strategic priorities document and is seeking public comments on how to ensure drug safety throughout a product's lifecycle.
- Novartis' Japan unit and a former employee were charged for allegedly manipulating data related to their blood pressure drug Diovan.
- The TGA published an updated summary of fees and is working to implement eCTD submissions for drug applications.
- The FDA filed a complaint seeking to permanently enjoin a California company from distributing vaginal drug products without approval.
- Industry groups in India are concerned about dependence on China for drug APIs and are calling for policies to promote
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
This document provides an introduction and overview of the Orange Book, formally known as "Approved Drug Products with Therapeutic Equivalence Evaluations". The Orange Book is published by the FDA and lists approved drug products and determines whether generic drugs are equivalent to brand name drugs. It identifies drug products approved by the FDA, determines therapeutic equivalence of generic drugs, and provides patent and exclusivity information to facilitate generic drug approval. The document outlines the history, contents, and objectives of the Orange Book in facilitating review of drug use and substitution of equivalent generic drugs.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
This document provides information on establishing and operating a community pharmacy. It defines a community pharmacy as privately owned establishments that serve a society's drug needs. Key aspects covered include selecting an accessible site, designing an ideal layout, meeting legal requirements for licensing and record keeping, properly dispensing medications, and maintaining appropriate patient, legal, and financial records. The goal is to provide convenient pharmaceutical services and products to customers while complying with regulations.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure quality, safety and efficacy. The TGA evaluates medicines and approves their inclusion on the Australian Register of Therapeutic Goods before they can be supplied in Australia. There are multi-phase approval processes for prescription medicines, over-the-counter medicines, and complementary medicines. Prescription medicines undergo the most rigorous evaluation and require registration, while some OTC medicines and most complementary medicines only require listing on the register. The approval process involves pre-submission planning, evaluation of quality and clinical data over multiple rounds, opportunities for additional information requests, and expert review before the final registration decision.
The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
The EMEA (European Medicines Agency) is a decentralized body of the European Union headquartered in London. It was established in 1995 and coordinates the evaluation and supervision of medicines for human and veterinary use throughout the EU. It is composed of various committees including the CHMP (Committee for Medicinal Products for Human Use) and CVMP (Committee for Medicinal Products for Veterinary Use) which are responsible for assessment and authorization of medicines. The EMEA ensures that medicines are evaluated based on quality, safety and efficacy with the goal of protecting public health.
The document discusses various financial issues related to pharmacy billing such as third party programs like private insurance, Medicare, and Medicaid; online adjudication of insurance claims; reasons claims may be rejected; and billing procedures including use of forms like the CMS-1500 and CPT codes. It also covers business math concepts used in pharmacy like mark-up, average wholesale price, and capitation fees.
Over-the-counter (OTC) drugs are medications that can be safely used without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for self-treatment of common health issues. The FDA reviews OTC products and establishes labeling regulations. There are two pathways for legal OTC drug marketing: compliance with an OTC drug monograph or approval under a new drug application. OTC drugs are generally low risk for abuse and allow for wider access and treatment of minor conditions. Proper labeling, safety, efficacy, and manufacturing standards are required of all OTC drugs.
Canadian policy for combination (drug / device) productsJasmin NUHIC
The purpose of this policy is to ensure timely access to drug/medical device combination products by
establishing a single window approach and more efficient submission processing system, while ensuring
that combination products marketed in Canada are safe, effective, and of high quality.
This document discusses drug procurement in hospitals. It defines procurement as acquiring supplies through purchases from manufacturers or distributors. The roles of the purchasing agent and pharmacist in drug procurement are described. The purchasing agent is responsible for issuing purchase orders, maintaining orders, following up on delays, and obtaining quotations. The pharmacist maintains supplier contact information, prepares specifications and forms, and receives drug shipments. Strategies for effective procurement include obtaining cost-effective drugs in the right quantities from reliable suppliers in a timely manner at the lowest possible cost. Methods of procurement include direct purchase, bids, contracts, and local purchase. Community pharmacy procurement involves selecting medicines, identifying financial position and suppliers, negotiating terms, and monitoring orders.
Presented at the 4th Global Animal Health Conference 2015 #GAHC2015 on Regulatory Convergence. Held in Dar Es Salaam, Tanzania, 24-25 June 2015.
This was presented by GALVmed consultant Gilly Cowan and discussed GALVmed's progress in following up the recommendations from the 2010 Global Animal Health Conference when African regulators asked for a harmonised registration system, mutual recognition and training for their regulators in the registration of veterinary vaccines.
GALVmed, the Global Alliance for Livestock Veterinary Medicines, works through its partners to protect livestock and improve human lives by making livestock vaccines, diagnostics & medicines accessible and affordable to the millions of those who rely on livestock.
For more information on this conference, hosted by Health For Animals (formerly IFAH), visit here: http://healthforanimals.org/global-animal-health-conference-addresses-regulatory-barriers/
To read more highlights from the conference, click here: https://twitter.com/hashtag/GAHC2015?src=hash
Current mci guidelines for pharmaceutical companies and governmentKamal Singh
The document discusses current guidelines from the Medical Council of India (MCI) and the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) regarding relationships between doctors and the pharmaceutical industry. The MCI code addresses gifts, travel, hospitality, cash/grants, medical research standards, and professional autonomy/endorsements. The UCPMP, adopted by the pharmaceutical industry from January 2015, involves general promotion approval/consistency, evidence-based product claims/comparisons, representative ethical standards, and sample authorization/quantity limits. It also regulates interactions like gifts, travel, and payments between companies and healthcare professionals.
Drug information center in a retail Drug StoreYamini Shah
This document provides an overview of drug information centers. It discusses the objectives, classification, requirements, resources, functions, and need for drug information centers. It also lists some drug information centers in India and the roles of drug information specialists. Computerized services and resources used by drug information centers are also outlined.
This issue of Pharma Uptoday provides news and updates from the pharmaceutical regulatory world. Key highlights include:
- The MHRA says it provided free expert advice to AstraZeneca on building a new UK manufacturing plant, and this help is available to all drugmakers.
- Common deficiencies cited in MHRA inspections relate to manufacturers' quality systems.
- An API plant of Dr. Reddy's in India received a US FDA Form 483 with nine observations primarily related to procedural compliance issues.
- Various regulatory agencies like Health Canada, TGA, and the Indian government announce new guidances, regulations, and plans to improve clinical trial quality standards.
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
This document provides a summary of news and regulatory information related to the pharmaceutical industry. Key points include:
- The FDA released its strategic priorities document and is seeking public comments on how to ensure drug safety throughout a product's lifecycle.
- Novartis' Japan unit and a former employee were charged for allegedly manipulating data related to their blood pressure drug Diovan.
- The TGA published an updated summary of fees and is working to implement eCTD submissions for drug applications.
- The FDA filed a complaint seeking to permanently enjoin a California company from distributing vaginal drug products without approval.
- Industry groups in India are concerned about dependence on China for drug APIs and are calling for policies to promote
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
This document provides an introduction and overview of the Orange Book, formally known as "Approved Drug Products with Therapeutic Equivalence Evaluations". The Orange Book is published by the FDA and lists approved drug products and determines whether generic drugs are equivalent to brand name drugs. It identifies drug products approved by the FDA, determines therapeutic equivalence of generic drugs, and provides patent and exclusivity information to facilitate generic drug approval. The document outlines the history, contents, and objectives of the Orange Book in facilitating review of drug use and substitution of equivalent generic drugs.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
This document provides information on establishing and operating a community pharmacy. It defines a community pharmacy as privately owned establishments that serve a society's drug needs. Key aspects covered include selecting an accessible site, designing an ideal layout, meeting legal requirements for licensing and record keeping, properly dispensing medications, and maintaining appropriate patient, legal, and financial records. The goal is to provide convenient pharmaceutical services and products to customers while complying with regulations.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to ensure quality, safety and efficacy. The TGA evaluates medicines and approves their inclusion on the Australian Register of Therapeutic Goods before they can be supplied in Australia. There are multi-phase approval processes for prescription medicines, over-the-counter medicines, and complementary medicines. Prescription medicines undergo the most rigorous evaluation and require registration, while some OTC medicines and most complementary medicines only require listing on the register. The approval process involves pre-submission planning, evaluation of quality and clinical data over multiple rounds, opportunities for additional information requests, and expert review before the final registration decision.
The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
The EMEA (European Medicines Agency) is a decentralized body of the European Union headquartered in London. It was established in 1995 and coordinates the evaluation and supervision of medicines for human and veterinary use throughout the EU. It is composed of various committees including the CHMP (Committee for Medicinal Products for Human Use) and CVMP (Committee for Medicinal Products for Veterinary Use) which are responsible for assessment and authorization of medicines. The EMEA ensures that medicines are evaluated based on quality, safety and efficacy with the goal of protecting public health.
The document discusses various financial issues related to pharmacy billing such as third party programs like private insurance, Medicare, and Medicaid; online adjudication of insurance claims; reasons claims may be rejected; and billing procedures including use of forms like the CMS-1500 and CPT codes. It also covers business math concepts used in pharmacy like mark-up, average wholesale price, and capitation fees.
Over-the-counter (OTC) drugs are medications that can be safely used without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for self-treatment of common health issues. The FDA reviews OTC products and establishes labeling regulations. There are two pathways for legal OTC drug marketing: compliance with an OTC drug monograph or approval under a new drug application. OTC drugs are generally low risk for abuse and allow for wider access and treatment of minor conditions. Proper labeling, safety, efficacy, and manufacturing standards are required of all OTC drugs.
Canadian policy for combination (drug / device) productsJasmin NUHIC
The purpose of this policy is to ensure timely access to drug/medical device combination products by
establishing a single window approach and more efficient submission processing system, while ensuring
that combination products marketed in Canada are safe, effective, and of high quality.
TGA Presentation: Medicines scheduling and scheduling policy ad hoc working g...TGA Australia
TGA Scheduling Working Group Meeting One February 2018. Role of the Working Group including Reforms to the advertising of S3 pharmacist only medicines, Reviewing what current S3 substances should be advertised, Proactively identifying S4 medicine substances for consideration for down-scheduling, Adding a new appendix to the poison standard to provide additional safeguards when down-scheduling
The document discusses the marketing and regulation of over-the-counter (OTC) drugs, including the differences between OTC and prescription drugs, the OTC drug review process conducted by the FDA, and the role of pharmacists in counseling patients on the safe and effective use of OTC medications. Key points covered include the benefits and risks of OTC drug use, the FDA approval pathways for OTC products, and best practices for pharmacist counseling on OTC selections and their appropriate use.
The document outlines proposed standards for registered pharmacies in the UK. It introduces draft standards focused on outcomes for safe and effective pharmacy practice. The standards aim to protect patients while providing flexibility for pharmacies. Responsibility for meeting the standards lies with pharmacy owners and superintendent pharmacists.
The document outlines the regulation of medicines in South Africa. It discusses the key pieces of legislation, the Medicines Control Council (MCC) mandate to regulate medicines, clinical trials, and manufacturers. It also covers flexibilities in the law around access like compassionate use. Current challenges include inspection capacity and emerging areas like advanced therapies. Regulation of biosimilars follows EMA guidelines largely. Global cooperation among regulators is important for efficiency and responsiveness.
This document provides an overview of the drug approval processes in the United States, Europe, and India. In the US, drugs must undergo investigational new drug application and new drug application processes with the FDA, including clinical trials and demonstrating safety and efficacy. Europe has a centralized process through the EMA for certain drugs and mutual recognition or national processes for others. India requires new drugs to conduct clinical trials and submit a new drug application to the DCGI to prove safety and effectiveness in the Indian population. While requirements vary between regions, the overall goals are to safeguard public health by ensuring pharmaceutical quality, safety and efficacy.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
This document provides definitions and explanations of key concepts and terms related to regulatory affairs in the pharmaceutical industry. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and describes their main roles as ensuring safety, efficacy and quality of drugs; ensuring appropriate product information; and acting as a liaison with regulatory agencies in submissions and ensuring compliance. It goes on to define various application types such as NDA, ANDA, IND, MAA, DMF and ASMF. It also covers regulatory guidelines, agencies and procedures.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
This document summarizes recent legal issues affecting the practice of pharmacy in North Carolina. It discusses proposed state bills on pharmacy technician responsibilities in hospitals and pharmacist vaccination authority. It also outlines recent statutes on drug donation programs and upcoming elections for the North Carolina Board of Pharmacy.
This document discusses pharmaceutical laws and regulations, including topics like pharmaceutical legal systems, drug nomenclature, labeling and packaging requirements, and administration/quality assurance. It provides details on different types of laws (e.g. civil law, criminal law, administrative law), regulations, and how they apply to the pharmaceutical industry. Labeling and packaging requirements are also summarized, including what information must be included on labels according to regulations.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
This document provides a summary of common regulatory affairs job interview questions and answers. It begins with defining regulatory affairs and its goals of protecting human health, ensuring drug safety and efficacy, and ensuring accurate product information. It then discusses the roles of regulatory affairs professionals in interacting with regulatory agencies, preparing submissions, and ensuring compliance. The rest of the document provides answers to common interview questions about regulatory submissions, guidelines, authorities, and key concepts and legislation related to drug approval.
The document discusses a presentation given by Anne Burns from the American Pharmacists Association on the expanding role of pharmacists. It outlines 4 learning objectives related to describing the evolution of pharmacists providing direct patient care as part of integrated health teams, identifying challenges to full integration, reforms to laws and regulations, and the value pharmacists provide in preventing prescription drug misuse. The document also provides an overview of pharmacists' training and scope of practice under collaborative practice agreements, with examples from different states.
Similar to Background note for ad hoc group on med (20)
A form for GPs and practice staff to refer their patients to a community pharmacy for a Medicines Use Review or to be enrolled in the New Medicines Service.
Self selction of p medicines the journeyJames Andrews
The document discusses proposed changes to standards regarding self-selection of pharmacy medicines. It notes arguments for and against enabling self-selection, and proposes drafting compliance guidance on the issue rather than including prescriptive prohibitions in the standards. The guidance would be subject to consultation and published in early 2013, with the current prohibition on self-selection remaining in place until then. It seeks feedback on the proposals and risks to address.
0612 c public session minutes confirmedJames Andrews
The Council meeting covered the following key points in 3 sentences:
The Council approved the summary report on the consultation to modernize pharmacy regulation, the Fees Rules for 2012, and the GPhC's Annual Report and Accounts for 2011-2012. An investment policy for the GPhC was established. Performance monitoring reports were discussed and it was agreed that a group would meet to further develop targets and success indicators.
The General Pharmaceutical Council (GPhC) conducted a consultation from February to May 2012 on proposed new standards for registered pharmacies in Great Britain. The consultation received 456 responses from individuals and organizations. This document summarizes the key aspects of the consultation, including who provided feedback, the main topics covered, and the GPhC's process for analyzing responses. The GPhC is seeking the Council's agreement on publishing a summary of the consultation responses and on issues identified for further consideration before finalizing the new standards.
The minutes summarize a council meeting of the General Pharmaceutical Council held on January 12, 2012. Key items discussed included a consultation on draft standards for registered pharmacies, priority changes to pharmacy legislation, recommendations on developing a model for pharmacist revalidation, and performance monitoring reports. The council agreed to proposals on these issues and noted updates from the Chief Executive.
The document provides minutes from a Council meeting held on November 10, 2011. Key discussions and decisions included:
- Approval of the rolling corporate plan for 2012-2015 with additions around quality assurance of pre-registration training and a review of continuing professional development.
- Agreement to the proposed approach to consulting on regulation of pharmacy premises standards subject to review of draft standards.
- Approval of the Equality, Diversity and Inclusion Scheme and prosecution policy.
- Agreement to maintain the emergency registration policy with planned review in late 2012.
- Noting of performance updates and financial reports.
11.11 co2 regulation of pharmacy premisesJames Andrews
The document discusses the General Pharmaceutical Council's proposed approach to regulating registered pharmacy premises in the UK. It provides an overview of pre-consultation engagement work conducted to develop a regulatory framework. The Council is asked to note the engagement work and consider approving the proposed approach to a public consultation on draft standards for pharmacy businesses. The consultation would cover registration criteria, standards, compliance guidance, and the Council's enforcement powers approach.
The minutes summarize a council meeting of the General Pharmaceutical Council held on October 20, 2010 in London. Key discussions included approving guidance on preliminary investigations of council members, terms with external auditors, consulting on new education standards for pharmacists and accreditation methodology, a regulatory standards policy, and consulting on a CPD framework and rules. Performance monitoring reports and the transition of regulatory responsibility from the Royal Pharmaceutical Society were also discussed.
The Council is asked to agree a regulatory standards policy that sets out the GPhC's approach to developing, publishing, monitoring, and reviewing pharmacy practice standards and guidance. The policy establishes principles like ensuring patient safety, relevance, and transparency. It describes engaging stakeholders in standards development and issuing guidance to support implementation. The standards will form the basis for regulatory decisions and be monitored over time for continued relevance.
I e-mailed the GPhC and asked for "a straight-forward but full explanation of the decision making process" behind allowing P-medicine self-selection.
This is what they sent me.
1. Briefing note: Modernising Pharmacy Regulation: Ad hoc group on medicines related
standards
Purpose of the meeting
To ensure all relevant issues are identified and considered to enable the executive to
present suitable information and advice to Council as part of their consideration and
approval of standards for registered pharmacies, particularly in relation to medicines safety
and the interaction with medicines legislation and the medicines regulator, MHRA.
Context
The draft of the standards issued for consultation was developed with a number of key
underlying principles:
Council’s vision and strategy: including the desire to regulate in a way which is
proportionate and allows innovation which is consistent with high quality practice
Our policy in relation to standards setting: which endorsed the principle of outcome
focussed standards (and the need to consider additional supportive information and
guidance)
Consistent with the legal framework: The recognition that registered pharmacies will
need to comply with the law, but just because they are operating within the law, does
not mean that they are necessarily meeting our standards
That we need to consider the role of others: In some specific areas there is likely to be a
role for others areas of practice, as with professional standards, where leadership or
representative bodies may be better placed to provide guidance to registrants
Overarching principle
Patient safety comes first. If there is a risk to patient safety which is so serious it requires
regulatory activity we should do so if it is within our remit. If not, we should make clear
our views to others who do have a role, either at a local or national level.
Background and approach
In attempting to provide clarity about out role and the way in which we wish to regulate, a
number of specific issues have arisen, particularly in relation to how we interpret the
Medicines Act 1968 which is both complex and dated.
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2. In some areas (for example, the supply of medicines) the previous regulator was very
prescriptive about what was required. In areas where there was a regulatory interface with
the MHRA we have identified a need for much greater clarity about how we each interpret
legislation and apply policies in an operational context (not least inspections of sites which
are both registered pharmacies and MHRA licensed sites).
We see it as critical to the confidence of patients, the public and registrants that we meet
our commitment to the five core principles for good regulation (proportionate; accountable;
consistent; transparent and targeted). It is important, however, to note that there may be
circumstances (see overarching principle above) where an activity or practice is not
prohibited in law but a proportionate response may still be to create a rule or standard
which has the effect of a blanket prohibition.
Specific issues
Having considered the above principles and approach in drafting the consultation document
there are a number of specific issues which have been identified as needing further
discussion now that our consultation, Modernising Pharmacy Regulation, has closed (the
Council will receive a report of the consultation and engagement feedback at their meeting
in June ).
1. The requirement to supply of medicines with a marketing authorisation (MA) in
preference to a medicine that does not (i.e. the supply of a licensed medicine where one
exists in preference to an unlicensed medicine)
2. The extemporaneous preparation of methadone (which was specifically ‘allowed’ by the
RPSGB despite being an unlicensed medicine)
3. The manufacturing of medicines by pharmacies (under an exemption set out in section
10 of the Medicines Act)
4. The display of pharmacy medicines (P) which the RPSGB stated should not be available
for ‘selection’ by a patient.
The current draft of our standards do cover each of the issues above, but by being outcome
focussed do not seek to impose a blanket prohibition (or in the case of extemp. preparation
of methadone, enable it).
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3. Each of the issues has been raised as part of our consultation and in considering how best to
response Council will need to consider each of the following questions:
I. Do our standards comply with our own policy in relation to regulatory standards and
approach to regulation more generally?
II. Do our standards, as they are currently drafted, contradict the current legal
framework for medicines?
III. On these specific medicines related issues:
a. Is it the GPhC or the MHRA who is the lead regulatory body?
b. Do we need to defer to, or reference, expert advice from another
organisation?
c. If not, and we decide that the GPhC needs to provide clear and definitive
advice or requirements to its registrants, does that best sit with individual
registrants through CEP or associated guidance or to owners and SI’s through
registered pharmacy standards?
d. What should the standard, or guidance, say?
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4. Appendix (factual information in relation to the three identified issues)
1. The supply of medicines with a marketing authorisation where these exist (i.e. the
supply of a licensed medicine in preference to an unlicensed medicine where one
exists)
GPhC interim standards
Ensure products with a marketing authorisation are supplied where such products exist in a
suitable form and are available, in preference to unlicensed products or food supplements
except where an exemption has been authorised (the GPhC has granted an exemption for
the extemporaneous preparation of methadone).
Background Information
All medicinal products placed on the UK market require a ‘marketing authorisation’
(formerly known as a product licence). They are generally referred to as licensed medicines.
The authorisation is intended to provide assurance that a product’s safety has been
assessed before marketing, together with its efficacy.
Some licensed medicines are prescribed ‘off label’ this means that the medicine is used for
an indication outside of the terms of its marketing authorisation. An example is 1%
hydrocortisone cream. This is a licensed medicine, but it is not licensed for use on the face.
However, some doctors will prescribe it for use on the face. This is lawful. The prescribing
doctor and supplying pharmacist must both be satisfied that it is appropriate for the patient.
Some medicines are unlicensed. This means that they do not have a marketing authorisation
and have not been subject to clinical trials and the same regulatory oversight by the MHRA.
A lot of children’s medicines are either unlicensed or of label – however often this will be
because a licensed medicines does not exist.
Legislation
The Medicines for Human Use (Marketing Authorisation etc) Regulations 1994 (‘the Regs)
explain that no relevant medicinal product should be placed on the market unless it has an
MA. (Reg 3 (1) of the Regs).
This does not apply to anything done in a registered pharmacy, a hospital or health centre,
that is done there by or under the supervision of a pharmacist, and consists of procuring the
manufacture or assembly of a stock of relevant medicinal products with a view to dispensing
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5. them in accordance with a bona fide unsolicited order formulated in accordance with the
specification of a doctor or dentist and for use by his individual patients on his direct
personal responsibility (as set out in the MHRA guidance note 14).
This means that it is lawful for a pharmacist to supply an unlicensed medicine in response to
a prescription from a doctor or dentist.
GMC Guidance
The General Medical Council has recently reviewed its guidance on prescribing. Details of
the issues it considered and the interim position they have recently agreed are set out in
their Council Paper attached separately.
2. The extemporaneous preparation of methadone
GPhC interim standards
The GPhC has granted an exemption from the standard that requires products with a
marketing authorisation are supplied where such products exist in a suitable form and are
available, in preference to unlicensed products or food supplements.
Background
The Council agreed an exemption to its standards to enable the extemporaneous
preparation of methadone. The Council agreed at that time that the exemption would be
subject to review. Since then, we issued has held a call for evidence recognising that there
had been anecdotal concerns raised about the practice (See separate call for evidence). We
also raised this issue with the NPSA to ascertain if there is any further empirical evidence
about the safety of this practice.
Extemporaneously prepared methadone is an unlicensed version of the product which is
prepared in the pharmacy. There is a licensed version, however it has been a long
established practice within some pharmacies to prepare it on site, rather than purchase the
licensed version.
There is no detailed quantitative evidence to set out why, however our call for evidence
would suggest that there are two main motivations: the lack of storage space in some
pharmacies; and the reduced cost associated with the extemporaneously prepared version.
(The pharmacy is reimbursed at the same rate by the NHS Business Services Authority for
either version of the methadone).
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6. 3. The manufacturing of medicines by pharmacies (under an exemption set out in section
10 of the Medicines Act)
Background
Medicines must be manufactured by holders of the appropriate licences. This is a legal
requirement and is set out in the Medicines Act.
Under the supervision of a pharmacist in a registered pharmacy, (and some other settings,
including hospitals), medicines can be manufactured / prepared against a prescription,
without the need for a licence. This can happen under an exemption detailed in the Act.
The Act also allows pharmacists in registered pharmacies to prepare stock in advance to be
supplied at a later date for individual patients against a prescription.
Pharmacists can obtain stocks of both licensed and unlicensed medicines manufactured
elsewhere by holders of the appropriate licences and supply them to patients against
prescriptions.
The Act also allows pharmacists in registered pharmacies to manufacture certain medicines
and sell them over the counter to patients.
In our experience, there has been difficulty in working with the MHRA at an operational
which would benefit from greater clarity in supplementary guidance. We have, through a
series of meetings with the MHRA in recent months, received helpful verbal confirmation of
their view that if the manufacture is for a named patient, then the pharmacy is exempt from
the requirement to have an MHRA license. They further confirmed that they scale of the
manufacture is not a relevant criterion.
4. The display of Pharmacy (P) medicines
Background
Pharmacy medicines must be sold under the supervision of a pharmacist from a registered
pharmacy. This is a legal requirement and is set out in the Medicines Act.
The GPhC adopted, as an interim measure, the standard that P medicines cannot be made
available for self selection.
In a physical building that patients visit, this means that no P medicines can be accessed by
patients and the public without first speaking to a member of the pharmacy team. Some
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7. pharmacies may place dummy packs on the shop floor but the patient would need to speak
to a member of the pharmacy team before they could access the medicines themselves.
If a patient visits an internet pharmacy, they can browse all general sale list (GSL – these are
those medicines that you can buy from any retail outlet) and P medicines. The patient can in
effect ‘pick’ which medicines they wish to purchase. For P medicines, as is the case for a
physical pharmacy a pharmacist would need to supervise the sale and the sale would need
to take place from a registered pharmacy.
What we have heard
Although we are still analysing the responses from the consultation, we are aware that a
number of representative bodies from pharmacy have expressed concerns that this might
be a risk to patient safety and may undermine the categorisation process for medicines.
We are awaiting receipt of any relevant documentation about this process carried out by
the MHRA, but they appear unlikely to be able to give us a definitive view as to whether a
different interpretation of the legal requirement for supervision (such as self-selection)
would have led to different decisions on categorisations of medicines which have moved
from POM to P.
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