overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
A clinical trial is a culmination of the several stages of a drug or medical
device development program that begins with the discovery of a
candidate molecule followed by preclinical toxicology studies in ex vivo, in
vitro, and animal models. Once the candidate molecule shows promising
results in these stages, the next step involves clinical studies on human
subjects. Drug testing in humans is often the most lengthy and expensive
phase of the drug development timeline, and therefore requires extensive
effort and careful execution to maximize the candidate’s chances of
success. In addition to scientific evaluation, clinical studies require
approval by the United States Food and Drug Administration (US FDA),
the regulatory authority in the United States to administer the
experimental drug in humans as well as ship it across state lines. This
approval comes in the form of an Investigational New Drug (IND FDA)
application that is required to be submitted by sponsors, investigators, or
research institutes to the FDA to commence studies on human
participants. The following figure shows the various stages of the drug
development program (Figure 1) marking IND submission on the timeline.
The US Food and Drug Administration (FDA) has established a comprehensive drug
development strategy for US FDA. This strategy is designed to ensure that the drugs
being developed meet the highest standards of safety and efficacy.The IND is a comprehensive document that contains all the information
gained from preclinical and other studies in an organized format. The
FDA reviews and makes the decision to support further clinical studies
from information in the IND that ultimately forms the basis of marketing
approval. INDs can be submitted at any phase during clinical
development to protect the safety and rights of subjects (Phase I) and to
assure adequate scientific evaluation of the drug’s effectiveness and
safety (Phase II and III). The Code of Federal Regulations CFR Title 21.
Part 312 Investigational New Drug Application contains information on
INDs as well as their content and format and should be reviewed
thoroughly by sponsors or investigators prior to submission of an IND
application.
The IND data requirements are important for the development of new drugs and
medical devices. They provide detailed information about the safety and efficacy of a
drug or device before it can be approved for use by the public
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
Data integrity - Regulatory Perspective and Challenges: santoshnarla
Data Integrity: Regulatory Perspective and Challenges.
This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges.
Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
New guidelines relating to elemental impurities from the International Conference on Harmonization (ICH), Q3D Guideline for Elemental Impurities have presented the pharmaceutical industry with new challenges. This new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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.
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!
Regulatory affairs and Intellectual Property Rights
1. REGULATORY AFFAIRS &
INTELLECTUAL PROPERTY RIGHTS
Dr. Santosh Kumar Narla,
M.Pharm., Ph.D,
NAG Manager - Regulatory Affairs,
Dr. Reddys Laboratories, Hyd.
santoshmph@yahoo.com
2. My Brief :
Academics:
Awarded Ph.D (Pharmaceutical Sciences) from JNTUH (2008-2014),
M. Pharm (Pharmaceutics) from Roland, BPUT, Orissa,
B. Pharm from G.Pullareddy, OU, Hyderabad,
D. Pharm from SBTET, Tirupati.
Holding 15+ years of professional experience with Hands on experience for Formulation
Development and Regulatory Affairs.
Currently Working as NAG Manager - Formulation Regulatory Affairs, Dr. Reddys
Laboratories, Hyderabad.
Previously associated with Laurus Labs, Novartis, Medreich and Aurobindo Pharma.
Presented many oral presentations as INVITED SPEAKER in national and international
conferences.
Published 3 Research and 4 Review articles in International Journals.
2
Disclaimer:
The view and opinions expressed are those of presenter and do not necessarily
represent the view of Dr. Reddy’s Laboratories.
3. Types of Healthcare industries:
Drug Industry
• Pharmaceutical Industry
• Biotech Industry/Biologics
• Medical Device/Diagnostics Industry
• Functional food and natural health products
/ Nutraceuticals
Stages in New Drug Development:
1. Drug Discovery/Basic Research
2. Pre-Clinical Testing
3. Investigational New Drug Application (IND)
4. Clinical Trials
4.1) Phase I Clinical Trials
4.2) Phase II Clinical Trials
4.3) Phase III Clinical Trials
5. New Drug Application (NDA) / Biologics License Application (BLA)
6. Clinical Trials Phase IV and Beyond
3
6. 1) Drug Discovery/Basic Research:
It is the first phase of the drug development process
Researchers try to understand the mechanism of a certain disease.
Researchers look for new molecule with promising activity against disease.
Also studied: safety, toxicity and metabolic effects.
➢ Determine the target disease
➢ Determine each component of disease :
▪ Symptoms
▪ Target organ
▪ Biochemical pathways
➢ Search for the target drug : -
• Naturally screened compound (extracts)
• Chemically synthesized compound
• Biologically synthesized compound
• Computer simulated compound
➢ Isolate the compound
➢ Proceed to next Stage
6
7. 2) Pre CLINICAL TRIALS:
✓ Conducted in ANIMALS and in vitro.
✓ To establish, drug is safe for use in clinical studies (HUMANS).
✓ To assess primary safety & activity.
Studied for:
➢ Synthesis and purification of the new drug
➢ Pharmacology of the new drug in ANIMALS:
Pharmacokinetics and Pharmacodynamics
Toxicology (carcinogenicity, teratogenicity …)
Evaluation of acute and short term toxicity. It Involves :
To assess primary safety & activity
Lethal dose determination
Effect of dose at normal level for short/Long term
FDA expectations:
(1) Pharmacological profile of the drug;
(2) Acute toxicity of the drug in at least two species of animals,
(3) Short-term toxicity studies 2weeks to 3months.
7
8. 3) Investigational New Drug application (IND):
Application for conducting the Clinical Trials.
Apply to FDA with all of your lab and animal study data.
Along with a proposed clinical trial design
FDA reviews the IND application mainly for HUMAN safety.
4) Clinical Trials:
Clinical Trials are performed on humans.
The purpose of a clinical trial is to prove or disprove a hypothesis.
Active Clinical Trials are listed at ClinicalTrials.gov.
Overview of Clinical Study Phases:
Phase 1: Safety and tolerability studies on healthy volunteers
Phase 2: Clinical studies to demonstrate proof of concept and dose findings
Phase 3: Efficacy and safety studies on large number of subjects
NDA regulatory review
Phase 4: Post-marketing safety studies
8
9. 4.1: Phase I Clinical Trials:
➢ Conducted in 20-100 healthy volunteers.
➢ Mainly focus on drug safety
➢ Effects of the drug as a function of dosage
➢ Establish limits of safe clinical dosage range.
➢ Following is studied here :
Initial safety & tolerability studies
Drug absorption/Metabolism in human.
Effect on organs and tissues.
Side effect of different dosages.
Thus early evidences on effectiveness are achieved.
9
10. 4.2: Phase II Clinical Trials:
➢ Drug given to 100 - 500 patients.
➢ Mainly focus on effectiveness.
➢ Drug is tested for the first time in patients with the target
disease.
➢ To determine efficacy, safety, optimum dose.
➢ Evaluate short-term side-effects and risks.
➢ Compared to placebo or standard drug.
4.3: Phase III Clinical Trials:
➢ Drug given to 1000-5000 patients
➢ Following is studied here:
Confirm efficacy
Safety of Drug [Benefits v/s risk analysis]
Long term side effects in patients
Investigates different populations combination with other drugs
Compare to commonly used treatments
Designed to minimize errors by placebo effects
10
11. 5) New Drug Application (NDA):
Application to market a new drug for sale in the U.S.
Safety and efficacy study in large population.
Preclinical and Clinical data will be part of the NDA.
Also included: Chemistry, Manufacturing and Control (CMC)
Inspection of production facilities.
Proposed labeling is appropriate??
6) Phase 4 / Market Launch:
launched to the Market (Post-market optimization).
Long term safety, efficacy under actual conditions of use.
Studied in very large numbers of patients: ADR.
Additional post marketing testing of patients to:
✓ Support the use of the approved indication.
✓ Finding new therapeutic opportunities.
✓ Extending use of the drug to children.
11
13. 13
API
Synthesis R&D
Analytical R&D
Technology Transfer
Developmental QA
Production
Quality Control
Quality Assurance
Packaging
Regulatory Affairs
Project Management
Business Development
Marketing
Intellectual Property Rights
Formulations
Formulations R&D
Analytical R&D
Technology Transfer
Developmental QA
Production
Quality Control
Quality Assurance
Packaging
Regulatory Affairs
Project Management
Business Development
Marketing
Intellectual Property Rights
Clinical Services
Pre-clinical research
Clinical research
Bio-Analytical R&D
Quality Assurance
SAS programmer
Statistician
Project Management
Business Development
Medical Research
Scope of Pharmacy – Indian Pharma Industry
15. 15
Types of Applications @ USFDA:
❖ Investigational New Drug (IND) Application
❖ New Drug Application (NDA)
❖ Abbreviated New Drug Application (ANDA): Generics
❖ Therapeutic Biologic Applications (BLA)
❖ Drug Applications for Over-the-Counter (OTC) Drugs
16. 16
dr.santoshkn@gmail.com
CTD documentation (also called Dossier)
Application format for NDA/ANDA/BLA
Common Technical Document:
Harmonised format for applications for preparing marketing
authorisation in the three ICH* regions (Europe, Japan, USA)
Structure of the CTD
*ICH: International conference
on harmonisation of technical
requirements for registration of
pharmaceuticals for human use.
The CTD is organized into 5 modules.
Module 1 is region specific and
modules 2 - 5 are intended to be
common for all regions (ICH format).
16
17. 17
Content of CTD:
Module NDA Content ANDA Content
Module 1 Administrative (forms/labeling etc)
Module 2
Summaries of
Module 3, 4 and 5
Summaries of
Module 3 and 5
Module 3 Chemistry, Manufacturing and controls (CMC)
Module 4*
Non clinical study reports
(Preclinical data/Animal data)
Not applicable
Module 5
Clinical study reports
(Phase I, II, III and IV)
Bioequivalence data
* For ANDA, Module 4 is not required in USA. In Europe, we need to keep the Literature data.
20. PHARMACEUTICAL MARKETS
Regulated Markets
USA – USFDA
Europe – EMA/MHRA…
Canada – Health Canada
Japan – PMDA
Australia – TGA
Semi-Regulated Markets
India, China, Brazil, Africa, Russia…
Non-regulated Markets
African countries – need minor documentation
20
21. KEY COMPONENTS OF REGISTRATION
Active substance info / DMF
Drug product development data
QbD data / DOE data
Analytical method development data
USP /EP method verifcations
Drug product batches executed data
Batch size / number of batches
Specification/ validations data
Comply to USP / EP / IP / BP
Process validation data of API, DP
Stability data of API, DP
Climatic zones data – Long term/ accelarated / Intermediate
Bioequivalency data / Clinical Data
Biowaiver / fast / fed / study state
Packaging information
In USA – DMF needed
Working standard data (USP/EP/IP)
Genotoxic / Elemental impurities data
Plant inspections / GMP status
Use of Right Reference product
21
24. Generic drug approval process:
6
Marketing Applications: Post-1984
New Drug Applications
(NDAs)
Abbreviated New Drug
Applications (ANDAs)
• “Full Reports” of Safety
and Efficacy Investigations
• Applicant has right of
reference to essential
investigations?
• Duplicate of an already
approved product
• No safety/efficacy data
permitted (only
bioequivalence)
YES NO
505(b)(1) 505(b)(2) 505(j)
25. Types of ANDA filing:
ANDA is for a generic duplicate of an approved NDA product. Abbreviated New Drug Application contains data
that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product:
•Gets safety and efficacy studies from NDA
•Must have identical active ingredient, route of administration, dosage form, strength, labeling and intended use
•Must demonstrate bioequivalence
www.fitzpatrickcella.com
7
Patent Information/Certification
• Generic applicant (either ANDA or 505(b)(2)) must
make one of the following certifications:
– (I) patent information on the listed drug not filed
– (II) patent has expired
– (III) the date on which such patent will expire
– (IV) patent is invalid, unenforceable or not
infringed
– (viii) method of use patent does not claim a use
for which applicant is seeking approval.
28. Exclusivities (NCE, NS, NP, NDF, PED, ODE, PC):
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run
concurrently with a patent or not.
NCE – New chemical entity – 5 years
NS – New salt – 3 years
NP – New product – 3 years
PED - Pediatric Exclusivity - 6 months added to existing Patents/Exclusivity
ODE - Orphan Drug Exclusivity - 7 years
PC - Patent Challenge – 180 days (this exclusivity is for ANDAs only
29. •New Chemical Entity (NCE) Exclusivity
◼Prohibits the filing of an ANDA (or 505(b)(2) NDA) for a product that contains the NCE for 5 years after
approval of the first NDA.
◼(4 years if ANDA includes a Paragraph IV challenge to listed patent)
◼NCE: "a drug that contains no active moiety that has been approved by FDA in any other [NDA].“
•3-Year Exclusivity
◼Available for NDAs which contain:
◼Reports of "new" "clinical trials"
◼That were "essential to approval" of the NDA
◼Conducted or sponsored by the applicant
◼FDA may not approve an ANDA or 505(b)(2) NDA for 3 years after approval
◼Applies for new indications, Rx → OTC switch, new dosing regimen, and some other labeling changes.
•Orphan Drug Exclusivity
◼7 year exclusivity
◼Drugs for rare conditions (<200,000 people in U.S.)
•Pediatric Exclusivity
◼6-month extension of existing patent or Waxman-Hatch exclusivity
•180-day generic (ANDA) exclusivity
30. EU REGULATORY PROCESSES
EU types of filling process (CP, NP, DCP, MRP)
The European system for the authorisation of medicinal products for human and animal use was
introduced in January 1995 with the objective of ensuring that safe, effective and high quality medicines
could quickly be made available to citizens across the European Union.
Marketing Authorisation Procedures
Procedures for application for a marketing authorisation
•Centralised procedure
•National procedure
•Mutual recognition procedure
•Decentralised procedure
31. www.diahome.org
Marketing Authorisation EU - Licensing of Medicines in the EU
Centralised
Procedure
Mutual Recognition
Procedure/DCP
One Pan- European
Marketing
Authorisation (MA)
MA in more than one
EU- Member State
MA in just one EU-
Member State
National
procedure
32. www.diahome.org
Protection Periods
➢ Regulatory Data protection
(= Data Exclusivity)
➢Protection of the registration documentation
➢6/10 years Old provision
➢8+2+1 years New provision
➢ Patent protection
International patent protection = 20 years
TRIPs: Agreement on
Trade-Related Aspects of Intellectual Property
Rights (1995)
33. www.diahome.org
Regulatory Data Protection - Generics
• 8+2+1 for all products – independent of
the approval procedure
➢ 10 (8+2) years market exclusivity
➢8 years data protection
➢2 years for generic companies to prepare, apply
for and receive a MA. The generic MAH is not
allowed to place his product on the market until 10
years have expired
34. www.diahome.org
Regulatory Data Protection - Generics
• +1 year
The ten-year period referred to in the second
subparagraph shall be extended to a maximum of
eleven years if, during the first eight years of those
ten years, the MAH obtains an authorisation for
one or more new therapeutic indications which,
during the scientific evaluation prior to their
authorisation, are held to bring a significant clinical
benefit in comparison with existing therapies
35. www.diahome.org
Protection
Extension if new therapeutic
indications
Ref. : Reg. 726/2004, Art. 14 and Dir. 2004/27/EC, Art. 10
Market Exclusivity
Years
Reference MP
initial
authorisation
5
1
0
0
Pre-clinical / clinical
data required*
*Bolar Clause
Data Protection
36. Launched in 1990, ICH is a unique undertaking that brings together the drug regulatory authorities and the
pharmaceutical industry of Europe, Japan and the United States. WHO, Canada, and EFTA are observers.
ICH stands for "International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use".
Six parties: Europe (EU & EFPIA), Japan (MHLW & JPMA) & USA (FDA & PhRMA).
37. ICH Products
• ICH guidelines: ICH guidelines classified majorly into 4 types:
•Quality guidelines
•Safety Guidelines
•Efficacy guidelines
•Multidisciplinary guidelines
• Electronic Standards for the Transfer of Regulatory Information (ESTRI, E2B)
• Common Technical Document (CTD & eCTD)
• Medical dictionary for adverse event reporting and coding of clinical trial data (MedDRA)
• Consideration documents
38. Quality Guidelines:
Q1A - Q1F Stability
Q2 Analystical validation
Q3A – Q3D Impurities
Q4 – Q4B Pharmacopoeias
Q5A – Q5E Quality of Biotechnological Products
Q6A – Q6B Specifications
Q7 Good manufacturing practice
Q8 Pharmaceutical development
Q9 Quality risk management
Q10 Pharmaceutical quality system
Q11 Development and Manufacture of Drug Substances
39. JOB SOURCES
LinkedIn / WhatsApp groups
Job sites: Naukri, Times job
Consultancies: Beware of high money demanding.
Googling for jobs for Pharma
39
dr.santoshkn@gmail.com
Visiting pharma news updates
Useful websites of Pharma from Global Research Online
(www.globalresearchonline.net)
Pharma Updates: RAPS Regulatory Focus, ECA Academy
GMP News, Pharmacompass.com.
40. 40
THANK YOU FOR YOUR ATTENTION, I HOPE THIS MESMERISES YOU ENOUGH
TO PREVENT YOU FROM ASKING DIFFICULT QUESTIONS!