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Pharmaceutical regulations for
drug approval in different countries
Prepared By;
Dr. Pankaj Bablani
1st Semester PhD Pharm...
Regulation in the industry
• Pharmaceutical industry is the most regulated of
all the industries. Regulations are put in o...
A Historical Perspective of drug regulation
and approval
 During the 20th century, there were no law’s & regulations to
p...
Thalidomide tragedy (1962)
• Thalidomide was first marketed in 1957 in West
Germany.
• The German drug company developed a...
JAKE-LEG” paralysis (1930)
The Ginger Jake poisonings
• A mysterious epidemic of paralysis was sweeping through 1920s Amer...
Elixir Sulfanilamide: (1937)
Taste of Raspberries, Taste of Death
• In 1937, more than 100 US citizens—many of whom
were c...
Elixir Sulfanilamide: (1937)
Taste of Raspberries, Taste of Death
• In 1937, more than 100 US citizens—many of whom
were c...
Such incidences/ tragedies led to
introduction of rules for the
approval of new drug
Pharmaceutical regulations for
drug a...
Pharmaceutical markets
• 1. Regulated -- USA, EU, Japan (Follows ICH paten. i.e. CTD)
• 2. Semi- Regulated – India, ASEAN-...
Pharmaceutical Regulatory Agencies
and Organizations around the World
• As the pharmaceutical industries throughout
the wo...
Pharmaceutical Regulatory Agencies
(Continue .. )
• In the present scenario, pharmaceuticals are
considered as the most hi...
An Overview of the drug approval
process
• Developing a new drug requires great amount
of research work in drug chemistry,...
Subjects
Purpose
Time
corse
New
drugs
pass
Laboratory
&
Animal study
Access safety &
Biological activity
1-2 years
100 %
2...
Review and Approval
• After phase III, the pharmaceutical company
prepares reports on all studies conducted on the
drug an...
Need for Regulation
• Drug reviewers in the regulatory agencies around the world have
responsibility of evaluating whether...
Regulatory agencies and organizations
established in countries.
• USFDA (USA)
• EMEA (European Union) International Confer...
The Drug approvals in the US, Europe & India
are the most demanding in the world. The
primary purpose of the rules governi...
USFDA
(United States of America)
EMEA
(European Union)
CDSCO
(India) 18
Drug approval in United States
• The United States has perhaps the world’s
most stringent standards for approving new
drug...
Drug approval in United States
Different types of drug applications that
can be submitted to FDA
• Investigational New Dru...
Investigational New Drug (IND)
21
New Drug Application (NDA)
22
Abbreviated New Drug Application
(ANDA)
23
Drug Approval in Europe
(28 member states)
• There are two regulatory steps to go through
before a drug is approved to be ...
TYPES OF PROCEDURES
• Centralized Procedure
• Decentralized Procedure
• Mutual Recognition Procedure (MRP):
25
Drug approval in Europe Union
Centralized procedure
The centralized procedure is one which allows
applicants to obtain a m...
Centralized procedure
27
Drug approval in Europe Union
Centralized process is compulsory for:
• Those medicines which are derived from any
biotechn...
Drug approval in Europe Union
Mutual Recognition Procedure
The Mutual Recognition procedure allows
applicants to obtain a ...
Drug approval in Europe Union
Mutual Recognition Procedure
• As soon as one Member State decides to evaluate
the medicinal...
Mutual Recognition Procedure
31
Drug approval in Europe Union
Decentralized procedure
• Using this procedure, companies may apply for
authorization simult...
Decentralized procedure
33
Drug approval in Europe Union
Nationalized Procedure
• The Nationalized procedure is one which allows
applicants to obtain...
• Through the International Conference on
Harmonization (ICH) process, the Common
Technical Document (CTD) guidance has be...
• Drug Regulatory Authority ensures that of
medicinal products are of acceptable Quality,
Safety and Efficacy which are Ap...
DRUG REGULATION SYSTEM IN INDIA
• When a company in India wants to
manufacture/import a new drug it has to apply to
seek p...
Drug Controller General of India
Clinical (DCGI)
• The office is runs under CDSCO. It has main
responsibility of regulatin...
Drug Controller General
of India
Deputy Drug
Controller
1. New Drug/
Ph’vigilance
3. Biological
& Vaccines
4. Drugs2. Medi...
Functions of CDSCO
• Approval of new drugs and clinical trials
• Import Registration and Licensing
• Licensing of Blood Ba...
Product categories
• 1. New Drug
• 2. FDC
• 3. Biologicals
• 4. Medical Devices.
• 5. Old drugs / Generics
41
Approval of Clinical Trials, Import, & Manufacture of New Drugs
Requirements and Guidelines - Schedule Y
• Rule 122 A -: P...
Pictorial representation of drug
approval process in India
43
Drug Approval in India
• But a provision is there in the Rule - 122A of the
Drugs and Cosmetics Act 1940 and Rules 1945
th...
TIME LINE & FEES FOR NDA
• It generally takes about one year to scrutinize
these documents by Data Associates/Drug
inspect...
Drug Approval in India
• As per the Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act
1940 and Rules 1945, drug sub...
Drug Approval in India
• the exact requirements of Clinical trials may
change from case to case and depend on the
extent t...
• Demonstration of safety and efficacy of the drug
product for use in humans is essential before the
drug product can be a...
New Drug Application (NDA)
• It is an application submitted to the FDA for permission to
market a new drug.
• To obtain th...
Drugs Technical Advisory Board (DTAB)
• Is a group of technical experts and they advice
the central and state governments ...
Drugs Consultative Committee
• It has central and state drug control officials as
members.
• Its main function is to ensur...
Different Phases of clinical trials:
• Pre clinical study - Mice, Rat, Rabbit, Monkeys
• Phase I - Human pharmacology tria...
53
Drug approval process
54
Principal differences between
US, EU, & India
Requirements US EU INDIA
Agency One Agency USFDA
Multiple Agencies
EMEA
CHMP...
Requirements US EU INDIA
CRO
(Audits)
Audited by
FDA
Audited by
MHRA
CDSCO
Reserve
Sample
5 times the sample
required for ...
Thank You For
your time
57
Name of the Guide/ Supervisor:
Dr. Manju Sharma
Assistant Professor
Department of Pharmacology
...
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Regulations for drug approval in USA, E.U & India

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Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.

Published in: Science

Regulations for drug approval in USA, E.U & India

  1. 1. Pharmaceutical regulations for drug approval in different countries Prepared By; Dr. Pankaj Bablani 1st Semester PhD Pharmaceutical Medicine (Batch 2014 – 15) Jamia Hamdard University New Delhi 1 Name of the Guide/ Supervisor: Dr. Manju Sharma Assistant Professor Department of Pharmacology Faculty of Pharmacy, Hamdard University New Delhi-110062, India
  2. 2. Regulation in the industry • Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million. • Regulatory affairs provides insight/guidance into this development through agency wisdom collected in guidance, previous experience, market precedence, etc. and hence helps to reduce number of development failures. 2
  3. 3. A Historical Perspective of drug regulation and approval  During the 20th century, there were no law’s & regulations to protect the public from the unfavorable effects of the drugs.  Misfortune, disaster, and tragedy had triggered most of the advances in drug regulation.  In a post-war era when sleeplessness was prevalent, thalidomide was marketed to a world obsessed on tranquilizers and sleeping pills. At the time, one out of seven people took them regularly. The demand for sedatives was even higher in some European markets, and the presumed safety of Thalidomide, the only non-barbiturate sedative known at that time, gave the drug massive appeal. Sadly, tragedy followed its release, catalyzing the beginnings of the rigorous drug approval and monitoring systems in place. 3
  4. 4. Thalidomide tragedy (1962) • Thalidomide was first marketed in 1957 in West Germany. • The German drug company developed and sold the drug. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension". • Afterwards, it was used against nausea and to ease morning sickness in pregnant women. • Soon, Thalidomide became an over the counter drug in Germany. • Shortly after the drug was sold in Germany, between 5,000 and 7,000 infants were born with Phocomelia (malformation of the limbs). • Only 40% of these children survived. • Throughout the world, about 10,000 cases were reported. Only 50% of the 10,000 survived. • Their effects included deformed eyes and hearts, deformed alimentary and urinary tracts blindness and deafness. 4
  5. 5. JAKE-LEG” paralysis (1930) The Ginger Jake poisonings • A mysterious epidemic of paralysis was sweeping through 1920s America that had the medical community baffled. The cause was first identified not by physicians, but by blues singers. • During the prohibition, alcohol was banned but people got buzzed the best way they could. One way was through a highly alcoholic liquid called Jamaica Gingeror ‘Jake’ that got round the ban by being sold as a medicine. • Eventually the feds caught on and even such poorly disguised medicines were blacklisted but Jamaica Ginger stayed popular, and alcoholic, due to the producers including an organophosphate additive called tricresyl phosphate that helped fool the government’s tests. • What they didn’t know was that tricresyl phosphate is a slow-acting neurotoxin that affected the neurons that control movement. • The toxin starts by causing lower leg muscular pain and tingling, followed by muscle weakness in the arms and legs. The effect on the legs caused a distinctive form of muscle paralysis that required affected people to lift the leg high during walking to allow the foot to clear the ground. 5
  6. 6. Elixir Sulfanilamide: (1937) Taste of Raspberries, Taste of Death • In 1937, more than 100 US citizens—many of whom were children—died after consuming Elixir Sulfanilamide, a raspberry-flavored antibiotic syrup manufactured by The S. E. Massengill Company of Bristol, Tennessee. The new, difficult-to-dissolve antibiotic, sulfanilamide, was mixed with the solvent Diethylene glycol, a known toxin, by the company’s • The company tested the elixir only for its appearance and palatability before its nationwide distribution. • The catastrophic event prompted the passage of the 1938 Federal Food, Drug, and Cosmetic Act. 6
  7. 7. Elixir Sulfanilamide: (1937) Taste of Raspberries, Taste of Death • In 1937, more than 100 US citizens—many of whom were children—died after consuming Elixir Sulfanilamide, a raspberry-flavored antibiotic syrup manufactured by The S. E. Massengill Company of Bristol, Tennessee. The new, difficult-to-dissolve antibiotic, sulfanilamide, was mixed with the solvent Diethylene glycol, a known toxin, by the company’s • The company tested the elixir only for its appearance and palatability before its nationwide distribution. • The catastrophic event prompted the passage of the 1938 Federal Food, Drug, and Cosmetic Act. 7
  8. 8. Such incidences/ tragedies led to introduction of rules for the approval of new drug Pharmaceutical regulations for drug approval 8
  9. 9. Pharmaceutical markets • 1. Regulated -- USA, EU, Japan (Follows ICH paten. i.e. CTD) • 2. Semi- Regulated – India, ASEAN-counties, Russia, China, Brazil. (Country specific product registration guidelines are followed) • 3. Non-regulated -- African counties. (Minimum documentation is required for drug approval process.) 9
  10. 10. Pharmaceutical Regulatory Agencies and Organizations around the World • As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. • Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country. 10
  11. 11. Pharmaceutical Regulatory Agencies (Continue .. ) • In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. • The regulatory body ensures compliances in legal and regulatory aspects of a drug. • Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. 11
  12. 12. An Overview of the drug approval process • Developing a new drug requires great amount of research work in drug chemistry, manufacturing, controls, pre-clinical science and clinical trials. • Drug development can generally be divided into phases.  The Preclinical phase  Clinical phases 12
  13. 13. Subjects Purpose Time corse New drugs pass Laboratory & Animal study Access safety & Biological activity 1-2 years 100 % 20-100 volunteers Safety & Dosage 3-4 years 70 % of IND 100-300 patients Effectiveness. Side effects 4-5years 33 %IND 1000-3000 patients Verify effectiveness. long term side effects 6-8 years 27 % File IND File N D A Clinical Phases Phase 1 Phase 2 Phase 3 Pre-clinical Phase IND - Investigational New Drug NDA - New Drug Application 13
  14. 14. Review and Approval • After phase III, the pharmaceutical company prepares reports on all studies conducted on the drug and submits the reports to the drug authority in a New Drug Application (NDA). • The drug authority then reviews this information to determine whether the drug is safe and effective for its intended use. • If the drug passes this review, it is approved for use in humans. 14
  15. 15. Need for Regulation • Drug reviewers in the regulatory agencies around the world have responsibility of evaluating whether the research data support’s the safety, effectiveness and quality control of a new drug product to serve the public health. • Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issuance of guidelines to regulate the marketing of the drugs. • Currently different countries have to follow different regulatory requirements for approval of new drug. • For Marketing Authorization Application, (MAA) a single regulatory approach is applicable to various countries is almost a difficult task. Therefore it is necessary to have knowledge about regulatory requirement for MAA of each country. 15
  16. 16. Regulatory agencies and organizations established in countries. • USFDA (USA) • EMEA (European Union) International Conference on Harmonization (ICH) • MHLW (Japan) Permanent members • CDSCO (India) • MHRA (UK) • TGA (Australia) • HEALTH CANADA (CANADA) • MCC (South Africa) • ANVISA (Brazil) • SFDA (China) • SWISSMEDIC (Switzerland) • KFDA (Korea) • MoH (Sri Lanka) • Others ….. 16
  17. 17. The Drug approvals in the US, Europe & India are the most demanding in the world. The primary purpose of the rules governing medicinal products in US, Europe & India is to safeguard public health. It is the role of public regulatory authorities to ensure that pharmaceutical companies comply with regulations. There are legislations that require drugs to be developed, tested, trailed, and manufactured in accordance to the guidelines so that they are safe and patient’s well - being is protected. 17
  18. 18. USFDA (United States of America) EMEA (European Union) CDSCO (India) 18
  19. 19. Drug approval in United States • The United States has perhaps the world’s most stringent standards for approving new drugs. • Drug approval standards in the United States are considered by many to be the most demanding in the world. • 19
  20. 20. Drug approval in United States Different types of drug applications that can be submitted to FDA • Investigational New Drug (IND) • It is an application filed to the FDA in order to start clinical trials in humans on the basis of the data obtained from the Preclinical trials. • Sponsor is responsible for submitting the IND application. • New Drug Application (NDA) • If clinical studies confirm that a new drug is relatively safe and effective, and will not pose unreasonable risks to patients, the manufacturer files a NDA, This is the actual request to manufacture and sell the drug in the United States. • Abbreviated New Drug Application (ANDA) • It’s an application made for approval of Generic Drugs. The sponsor is not required to reproduce the clinical studies that were done for the original, brand name product. • Instead, generic drug manufacturers must demonstrate that their product is the same as, and bioequivalent to, a previously approved brand name product • Biologic License Application (BLA) • Biological products are approved for marketing under the provisions of the Public Health Service Act. 20
  21. 21. Investigational New Drug (IND) 21
  22. 22. New Drug Application (NDA) 22
  23. 23. Abbreviated New Drug Application (ANDA) 23
  24. 24. Drug Approval in Europe (28 member states) • There are two regulatory steps to go through before a drug is approved to be marketed in the European Union. • These two steps are: • Clinical trial application Approved at the Member state level, • Marketing authorization application. Approved at both the Member state & at Centralized levels 24
  25. 25. TYPES OF PROCEDURES • Centralized Procedure • Decentralized Procedure • Mutual Recognition Procedure (MRP): 25
  26. 26. Drug approval in Europe Union Centralized procedure The centralized procedure is one which allows applicants to obtain a marketing authorization that is valid throughout the EU.  Results in a single authorization valid in EU, Norway, Iceland and Liechtenstein.  Application evaluated by an assigned Reporter.  Timeline: EMA opinion issued within 210 days, and submitted to European Commission for final approval. 26
  27. 27. Centralized procedure 27
  28. 28. Drug approval in Europe Union Centralized process is compulsory for: • Those medicines which are derived from any biotechnology processes, such as genetic engineering. • Those medicines which are intended for the treatment of Cancer, HIV/AIDS, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions. • Medicines officially designated 'Orphan medicines' (medicines used for rare diseases). 28
  29. 29. Drug approval in Europe Union Mutual Recognition Procedure The Mutual Recognition procedure allows applicants to obtain a marketing authorization in the Concerned member states (CMS) other Than the Reference member state (RMS), where the drug is previously approved. • Applicant submits identical dossier to all EU member states in which they want marketing authorization, including required information. 29
  30. 30. Drug approval in Europe Union Mutual Recognition Procedure • As soon as one Member State decides to evaluate the medicinal product (at which point it becomes the "RMS"), it notifies this decision to other Member States (which then become the "CMS"), to whom applications have also been submitted. • RMS issues a report to other states on its own findings. • Generic industry is the major user of this type of drug approval procedure. • This process may consume a time period of 390 days. 30
  31. 31. Mutual Recognition Procedure 31
  32. 32. Drug approval in Europe Union Decentralized procedure • Using this procedure, companies may apply for authorization simultaneously in more than one EU country for products that have not yet been authorized in any EU country and essentially do not fall within the centralized procedure’s essential drugs list. • Based on the assessment report which is prepared by the RMS & any comments made by the CMS, marketing authorization should be granted in accordance with the decision taken by the RMS & CMS in this decentralized procedure. • Generally used for those products that has not yet received any authorisation in an EU country. • Time: 210 days. 32
  33. 33. Decentralized procedure 33
  34. 34. Drug approval in Europe Union Nationalized Procedure • The Nationalized procedure is one which allows applicants to obtain a marketing authorization in one member state only. • In order to obtain a national marketing authorization, an application must be submitted to the competent authority of the Member State. • New active substances which are not mandatory under Centralized procedure can obtain marketing authorization under this procedure. • Timeline for this procedure is 210 Days. 34
  35. 35. • Through the International Conference on Harmonization (ICH) process, the Common Technical Document (CTD) guidance has been developed for Japan, European Union, and United States. • Most of the countries including India have adopted the CTD format. Hence, CDSCO has also has CTD format for technical requirements for the registration of pharmaceutical products for use in humans. 35
  36. 36. • Drug Regulatory Authority ensures that of medicinal products are of acceptable Quality, Safety and Efficacy which are Approved, Manufactured and Imported. • Drug Controller General of India (DCGI) is the head of Central Drug Standard Control Organization,(CDSCO) which regulates Drugs & Device in India. Drug Approval in India 36
  37. 37. DRUG REGULATION SYSTEM IN INDIA • When a company in India wants to manufacture/import a new drug it has to apply to seek permission from the, Drug Controller General of India (DCGI) by filing, Form 44 along with the data mentioned in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945. • In order to prove the efficacy and safety in Indian population a clinical trial in accordance with the guidelines specified in Schedule Y is to be conducted and a report of the trial is to be submitted in a specified format. 37
  38. 38. Drug Controller General of India Clinical (DCGI) • The office is runs under CDSCO. It has main responsibility of regulating clinical trials in India. • Matters related to product approval and standards, clinical trials, introduction of new drug, and import licenses of new drugs are handled by the DCGI. 38
  39. 39. Drug Controller General of India Deputy Drug Controller 1. New Drug/ Ph’vigilance 3. Biological & Vaccines 4. Drugs2. Medical Device Asst Drug Controller 39
  40. 40. Functions of CDSCO • Approval of new drugs and clinical trials • Import Registration and Licensing • Licensing of Blood Banks, & Medical Devices • Amendment to D &C Act and Rules • Banning of drugs and cosmetics • Grant of Test License, Personal License, NOCs for Export • Testing of Drugs 40
  41. 41. Product categories • 1. New Drug • 2. FDC • 3. Biologicals • 4. Medical Devices. • 5. Old drugs / Generics 41
  42. 42. Approval of Clinical Trials, Import, & Manufacture of New Drugs Requirements and Guidelines - Schedule Y • Rule 122 A -: Permission to import and market new drug • Rule 122 B -: Permission to manufacture new drug • Rule 122 DA -: Permission of Clinical trials/IND • Rule 122 E -: Definition of New Drugs 42
  43. 43. Pictorial representation of drug approval process in India 43
  44. 44. Drug Approval in India • But a provision is there in the Rule - 122A of the Drugs and Cosmetics Act 1940 and Rules 1945 that the licensing authority can give waiver to the trail. –If the authority believes that, it is in the interest of public health based upon the data of the trials conducted in other countries. –If the Drugs is approved and is being used for several years in other countries. 44
  45. 45. TIME LINE & FEES FOR NDA • It generally takes about one year to scrutinize these documents by Data Associates/Drug inspectors of CDSCO and during this period clarification if any, are required by them are answered and thereafter the importer gets the Approval. • Treasury Challan of Rs 50,000 – For fresh application. • Treasury Challan of Rs 15,000 – For subsequent application. 45
  46. 46. Drug Approval in India • As per the Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945, drug substances that are discovered in India are required to conduct all phases of trials. • Section 2.4 (b) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945, drug substances which are discovered in countries other than India; the applicant is to produce the data available from other countries and the licensing authority may require him to repeat the study or permit him to proceed to Phase III clinical trials. • Section 2.8 of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says that the licensing authority may require pharmacokinetic studies (Bioequivalence studies) first to show that the data generated in Indian population is equal to data generated abroad and then require him to proceed with Phase III trials. 46
  47. 47. Drug Approval in India • the exact requirements of Clinical trials may change from case to case and depend on the extent to which licensing authority is satisfied about its safety and efficacy. • The process of approval of new drug in India is a very complicated process, which should meet necessary requirements along with NDA to FDA. The need of the present work is to study and document the requirements for the process of approval of new drug in India with emphasis on clinical trials as per Drugs Control department, Government of India. 47
  48. 48. • Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing of new drug by the applicant by CDSCO. • The regulations under Drugs and Cosmetics Act 1940 and its rules 1945, 122A, 122B and 122D and further Appendix I, IA and VI of Schedule Y, describe the information required for approval of an application to import or manufacture of new drug for marketing. Drug Approval in India 48
  49. 49. New Drug Application (NDA) • It is an application submitted to the FDA for permission to market a new drug. • To obtain this permission a sponsor submits preclinical and clinical test data to NDA for analyzing the drug information, description of manufacturing procedures. • After NDA received by the agency, it undergoes a technical screening. This evaluation ensures that sufficient data and information have been submitted in each area to justify “filing” the application that is FDA formal review. • There are 3 possible actions that can send to sponsor: • Not approvable- List of deficiencies and explain the reason. • Approvable – The drug can be approved but minor deficiencies that can be corrected like-labeling changes and possible request commitment to do post-approval studies. • Approval- The drug is approved. 49
  50. 50. Drugs Technical Advisory Board (DTAB) • Is a group of technical experts and they advice the central and state governments on all technical matters arising out of the enforcement of drug control. • No rules can be made by the central government without consulting DTAB board. 50
  51. 51. Drugs Consultative Committee • It has central and state drug control officials as members. • Its main function is to ensure that the drug control measures and it’s enforcement is uniformly over all the states 51
  52. 52. Different Phases of clinical trials: • Pre clinical study - Mice, Rat, Rabbit, Monkeys • Phase I - Human pharmacology trial - estimation of safety and tolerability • Phase II - Exploratory trial - estimation of effectiveness and short term side effects • Phase III - Confirmatory trial - Confirmation of therapeutic benefits • Phase IV - Post marketing trial - Studies done after drug approval. 52
  53. 53. 53
  54. 54. Drug approval process 54
  55. 55. Principal differences between US, EU, & India Requirements US EU INDIA Agency One Agency USFDA Multiple Agencies EMEA CHMP National Health Agencies One Agency DCGI Registration Process One Registration Process Multiple Registration Process 1. Centralized (E.U - Community) 2. Decentralized (At least 2 member states) 3. Mutual Recognition (At least 2 member states) 4. National (1 member state) One Registration Process Application ANDA / NDA MAA MAA Debarment classification Required Not Required Not Required Number of copies 3 1 1 Approval Timeline ~18 Months ~12 Months 12 - 18 Months Fees Under $2 million-NDA Application $51,520 – ANDA Application National fee (including hybrid applications): £103,059 Decentralised procedure where UK is CMS: £99,507 50,000 INR 55
  56. 56. Requirements US EU INDIA CRO (Audits) Audited by FDA Audited by MHRA CDSCO Reserve Sample 5 times the sample required for analysis No such requirement - Retention of samples 5 years from date of filing the application No such requirement 3 years from date of filing the application Presentation eCTD & Paper eCTD Paper (Now started with e-CTD) Principal differences between US, EU, & India 56
  57. 57. Thank You For your time 57 Name of the Guide/ Supervisor: Dr. Manju Sharma Assistant Professor Department of Pharmacology Faculty of Pharmacy, Hamdard University New Delhi-110062, India

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