Regulatory affairs professionals play a crucial role in ensuring pharmaceutical products meet regulatory standards for safety, efficacy and quality. They provide strategic guidance to various departments on regulatory requirements and work to obtain approvals from regulatory authorities. Key responsibilities include filing product registrations, tracking legal changes, and facilitating clinical trials and product approvals. Regulatory affairs has become increasingly important given historical issues that prompted stronger drug regulations to protect public health.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
Drugs and Cosmetics Act 1940, 1945 Unit-I as per B. Pharm Pharmaceutical Juri...Sagarpamu123
This PPT covers the B. Pharm, Pharmaceutical Jurisprudence Unit-I topics with Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
Laws Regulating Drugs and Medical DevicesAshish vishal
This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
Laws regulating drugs and medical devices Ashish vishal
India has the 4th largest market for drugs and medical devices in Asia. The industry has been predicted to grow to be a $ 50 billion industry in less than 5 years by 2025.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
What Is the Scope of Pharmaceutical Regulatory Affairs In The USA.docxDDReg Pharma
Graduates with a Bachelor of Pharmacy (B.Pharm) degree have a wide range of employment options in the pharmaceutical and healthcare industries, as well as in research organizations, regulatory agencies, and academia.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
2. Contents
Introduction
Historical overview
Regulatory authorities
Role of Regulatory affair department
Responsibility of Regulatory Affair Professionals
Scope of Regulatory Affair Professionals in Industries
3. Introduction
Definitions:-
Regulation: it includes variety of texts (e.g, guidelines, recommendations,
procedures, policies etc) that have different legal bases and authority.
Drug Regulation: It is the control of drug use by international agreement/
regulatory authorities.
Pharmaceutical Regulations: defined as combination of legal administrative and
technical measures that government takes to ensure the safety, efficacy and
quality of medicines, as well as, the relevance and accuracy of product
information.
Regulatory Affairs: regulatory affairs typically refers to that group of scientists
who formulate the strategy for interacting with regulatory authorities in various
countries as well as tactics of securing responses to questions dealing with
submissions and maintaining communication post registration.
4. Regulatory Body: It is a public organization or government agency that is a set up to
exercise a regulatory function. This involves imposing requirements, conditions or
restrictions, setting the standard for activities, and enforcing in these areas or obtaining
compliance.
Regulatory Authorities: it is an autonomous authority or agency established by a federal,
state or provincial government.
5. Regulatory affairs (RA) professionals play a crucial role in pharmaceutical industry
and they provides strategic, tactical and operational direction and support to work
within regulations so as to accelerate product development and provide safe and
effective healthcare products or drugs to people around the world.
RA also known as Govt. Affairs, is a profession within regulated sectors such as
pharmaceuticals, medical devices, energy and banks.
6. Objectives of RA:
Provide strategic and technical advice to R&D, production and quality control dept.
File products in different markets.
Helps in getting approval from the regulatory bodies.
Tracks changes in legislation in the regions where the company distributes its
products.
Interpret and apply regulations.
Develop and implement regulatory strategies.
Collect, collate and evaluate scientific data.
Improve performance of existing functions or activities through regulatory affairs
personnel
Share training resources where possible and use systematic approach to training.
Provide advice to internal colleague on legal and scientific requirements.
7. Need for RA:
Drugs are meant for improving public health, therefore, their development, manufacture,
importation, subsequent handling and uses require specialized knowledge and skills and
should conform to prescribed standards to strictly maintain their quality.
Poor regulation can lead to release of standards, counterfeit, harmful and ineffective drugs
to national and international markets resulting in serious harm to health of consumers.
Main need is to provide the basis for assurance of high quality of drug products, which
can increase consumer’s interest for ensuring the efficacy, quality and safety.
9. Historical overview of RA:
In the era of 1950s, multiple tragedies resulted in substantial increase of
legislations and their strict implementation to maintain drug product quality, safety
and efficacy.
Some incidences are given as follows:
Diphtheria Act led to 1902 Biologics Control Act
Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act.
Elixir of Sulfonamide led to the 1938 Food Drug and Cosmetic Act.
Thalidomide led to the 1962 Kefauver- Harris Amendment.
Dalkon Shield led to the 1976 Medical Device Amendment.
Bjork- Shiley Heart Valves led to 1990 Safe Medical Devices Act.
10. India
Till 20th century, most of the drugs were imported from other countries.
After First World War, with the increase in the demand of the drugs, channels opened for
the substandard drug products in the market. To cope this situation, several regulations
were made time to time.
a. In the Era of 1900-1960:
Poisons Act 1919: to control cheap drugs and their flow in the market, possession of
substance specified as poison and their sale. Also describe safe storage of poisons,
labelling and packaging of the poisons, max quantity to be sold and the inspection &
examination of the poison sold by the seller in entire year.
Dangerous Drugs Act 1930: to regulate cultivation, manufacture, possession, import,
export and sale of opium and its plants.
Drugs and Cosmetics Act 1940: to regulate the import, production, distribution and
of drugs.
11. Pharmacy Act 1948: this law was amended lastly in 1986 and regulates the pharmacy
profession in India.
Drugs and Magic remedies (Objectionable Advertisements) Rules 1955: to control the
advertisement of drugs in India.
Drug Price Control Order (DPCO)1955: to review and fix maximum sale price for
formulations as well as bulk drugs. It was lastly amended in 1995.
b. In the Era of 1960-1990:
Indian pharmaceutical industries were in initial growth stage, due to dependency on
import, lack of R&D activities and existence of MNC’s in market.
Indian Patent Act 1970: to protect patent in India. Under this only the process and
manufacturing method of pharmacological substance obtained the patent. The product
patent was not allowed under this law. It replaced the Indian Patent and Design Act of
1911.
Narcotics and Psychotropic Substances Act 1985: issued to regulate the operation of
narcotic drugs and substances and revoked the Dangerous Drug Act 1930.
12. c. After the Era of 1990:
Rapid expansion and globalization of Indian pharmaceutical industry was
in this time period.
Paris cooperation Treaty 1999: India joined Paris Cooperation Treaty (PCT) in
1999,so as to protect Industrial property and patent rights in each of
contracting state and implemented product patent effective from 1st Jan
Patent Amendment Act 2005: The Patent (Amendment) Act 2005 defines
invention and clears about existing knowledge or thing cannot be patented.
Herbal preparations having medicinal values can be patented under new
amended law.
Drugs and Cosmetics (First Amendment) Rules, 2011: mandate the
of clinical research organization (CRO) to conduct clinical trials. Schedule Y1
D&C Act suggests the requirements and guidelines for registration of CRO.
13. Regulatory Authorities:
Any autonomous authority or agency established by a federal, state or provincial
government is known as regulatory authority.
Are established to enforce regulations on development and marketing of drug product
and also regarding occupational health and safety.
Country Regulatory Authority
USA United States Food And Drug Administration (USFDA)
UK Medicine And Healthcare Product Regulatory Agency
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization (CDSCO)
Europe European Medicines Evaluation Agency (EMEA)
14. International organizations
World health organization (WHO)
World trade organization (WTO)
International conference on Harmonization (ICH)
World intellectual property organization (WIPO)
These regulatory agencies and organizations play an important role in all aspects of
pharmaceutical regulations relating to the registration, production, distribution, price control,
marketing, research and development of pharmaceutical products and intellectual property
protection.
The main challenges are ensuring safety, quality and efficacy of medicines and medical
devices, harmonization of legal procedures regarding development of medicines, control and
compliance with legal obligations.
15. ROLE OF REGULATORY AFFAIR DEPARTMENT
DRA
Department
Quality
Assurance
Licensing
Product Development
Supplies and
Suppliers
Clinical Trials
Marketing
Manufacturing
Quality
control &
R&D
16. Role of RA Department:
It is a unique combination of science and management.
Success of regulatory strategy depends less on regulation than on the way in which they are
interpreted, applied, communicated within companies and to external components.
It is a first point of contact between government authorities and company and helps in
knowing, implementing and getting approval of these regulations laid down by various
authorities and performs many functions in pharmaceutical industries.
17. RA in Product Management:
Product registration and provide advice to companies both strategically and technically.
Role starts from product development to production, marketing and post-marketing strategies
and their advice at all stages, both in terms of legal and technical requirements.
For countries not having their own regulatory bodies and regulations, the guidelines of WHO on
Health and WTO on trade regulations are followed.
Also the RA officer makes sure that labelling and packaging is done according to the proper
guidelines given by regulation authority.
RA in Clinical Trials:
Develop strategies to overcome delays and submit the results of clinical trials to regulatory
agencies for quick authorization, reducing approval time for new molecules.
Also facilitates collection, analysis and communication of the risks and benefits of healthcare
products for regulatory agencies, healthcare and medical system and the public.
Also responsible for ensuring that market driven demands, government obligations and evolving
scientific conventions are understood clearly and addressed by multiple stakeholders.
18. RA in R&D:
RA department work together with marketing and research & development to develop novel
product by taking advantage of new technological and regulatory developments to accelerates time
to market.
The use of adaptive clinical trial strategies, obtaining rapid regulatory approval and eliminating
process difficulties can fasten the development of new products and helps in reducing costly errors
and delays.
RA in QA & QC:
RA department in collaboration with QC department submit dossier containing the collected
certificate of analysis, stability studies, analytical method validation reports and protocol for
registration of the product.
Collects Master Formula Records, process validation protocol, process validation report from QA
dept and reviews them before submitting the dossier to regulatory authorities so as to get
marketing approval or register the product.
19. RA in Licensing:
RA dept using its thorough knowledge and links with government or regulatory bodies
make the path easy to get license.
RA dept also take care of documentation part to get permission from from concerned
authorities.
RA in Gathering Information:
RA dept gathers and maintains information collected from regulators, expertise in drug
development, colleague.
RA uses this collected information on timely basis in order to ensure the compliance of
regulatory standards for production of safe and effective medicines and betterment of
company.