Different drug regularity bodies in different countries.

Various countries around the world have distinct drug regulatory bodies tasked with overseeing the safety, efficacy, and quality of pharmaceutical products within their borders. These regulatory agencies play a crucial role in ensuring that medications meet stringent standards before they reach consumers. In the United States, the Food and Drug Administration (FDA) is renowned for its rigorous evaluation processes, conducting thorough reviews of drugs before granting approval for distribution. Similarly, the European Medicines Agency (EMA) serves as the regulatory authority for the European Union, overseeing the approval and supervision of medicines across member states.

Other countries have their own equivalents, such as Health Canada's Health Products and Food Branch (HPFB) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). These bodies conduct comprehensive assessments of drugs through clinical trials, inspections of manufacturing facilities, and ongoing surveillance of adverse events. Additionally, they establish guidelines for labeling, packaging, and advertising to ensure transparency and consumer safety.

Despite differing in structure and procedures, these regulatory bodies share a common goal of safeguarding public health by upholding stringent standards for the pharmaceutical industry. Collaboration and communication between these entities are essential for fostering global consistency in drug regulation and promoting access to safe and effective medications worldwide.

1. Regularity bodies in different countries Presented by:- Kishan Singh Tomar m-pharm(pharmaceutics) 1 st year 21-03-2024

2. INTRODUCTION We need regulation for maintaining safety, efficacy and quality of medical product in every aspect. It is duty of different agency appointed by government or international committees to ensure and maintain SEQ of product in every domestic as well as international market. 21-03-2024 1

3. Countries and their regulatory bodies 21-03-2024 2

4. Countries and their regulatory bodies 21-03-2024 2

5. Countries and their regulatory bodies 21-03-2024 2

6. Countries and their regulatory bodies 21-03-2024 2

7. Countries and their regulatory bodies 21-03-2024 2

8. Countries and their regulatory bodies 21-03-2024 2

9. USFDA FDA Regulates:- Biologics Product and manufacturing establishment licensing Safety of the nation's blood supply Research to establish product standards and develop improved testing methods Cosmetics Safety Labelling Drugs Product approvals OTC and prescription drug labelling Drug manufacturing standards Foods Safety of all food products (except meat and poultry) Bottled water Medical Devices Premarket approval of new devices Manufacturing and performance standards Tracking reports of device malfunctioning and serious adverse reaction 21-03-2024 3

10. FDA regulates:- Radiation-Emitting Electronic Products Radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems, laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities Veterinary Products Livestock feeds Pet foods Veterinary drugs and devices FDA does not regulates:- Advertising (federal trade commission) Alcohol (Department bureau of alcohol) Consumer Products (Consumer product safety commission) Drugs of Abuse (Drug enforcement administration) Health Insurance (Health care financing administration) Meat and Poultry (USDAFSIS) Pesticides (FDA, USDA and Environmental protection agency) Restaurants and grocery stores (ILRAGS) Water (FDA & EPA) USFDA 21-03-2024 4

11. Tools of USFDA GMP (good manufacturing practices) GLP (good laborites practices) GCP (good clinical practices) CFR (code of federal regulation) How drug come to market USFDA 21-03-2024 5 Drug Discovery Preclinical drug testing Clinical phase I Clinical phase II Clinical phase III FDA review and Approval Country wise registration Post marketed surveillances Filling investigational New Drug (IND) Filling New Drug Application (NDA) New molecule Modified drug Change formulation New action/use Abbreviated New Drug Application (ANDA) not needed clinal trail

12. CDSCO Organization chart 21-03-2024 6

13. CDSCO Organization chart Laborites Postal office Sub Zonal office Zonal office Head quarters 21-03-2024 6

14. CDSCO Organization chart Laborites Postal office Sub Zonal office Zonal office Head quarters New drugs CLAA (Central Licensing Approval Authority) Import DTAB (Drug Technical Advisory Board) DCC (Drug Consultative committee) 21-03-2024 6

15. CDSCO Organization chart Laborites Postal office Sub Zonal office Zonal office Head quarters GMP audits Coordination with state GMP audits Coordination with state 21-03-2024 6

16. CDSCO Organization chart Laborites Postal office Sub Zonal office Zonal office Head quarters Import Export Inspection Document verification 21-03-2024 6

17. CDSCO Organization chart Laborites Postal office Sub Zonal office Zonal office Head quarters Testing of drug samples Validation of test protocols Report submission 21-03-2024 6

18. CDSCO Organization chart Laborites Postal office Sub Zonal office Zonal office Head quarters Testing of drug samples Validation of test protocols Report submission 21-03-2024 6 Testing of drug samples Validation of test protocols Report submission GMP audits Coordination with state GMP audits Coordination with state New drugs CLAA Import DTAB DCC

19. CDSCO Responsibility of CDSCO:- New Drugs Clinical Trials in the country laying down the standards for Drugs control over the quality of imported Drugs Import registration and provide NOC for export Testing of drugs Oversight and market surveillance through inspectorate of central over and above the state authority CDSCO is divided into:- State drug control authority Zonal & Sub zonal drug control authority 1. State drug control authority function :- Licensing of drug manufacturing and sales establishments Licensing of drug testing laboratories. Approval of drug formulations for manufacture. Monitoring the quality of Drugs & Cosmetics, manufactured respective state units and those marketed in the state. Investigation and prosecution in respect of contravention of legal provisions. Administrative actions 21-03-2024 7

20. Zonal office North Zonal South Zonal East Zonal West Zonal 21-03-2024 8

21. Zonal office North Zonal South Zonal East Zonal West Zonal 21-03-2024 8

22. Zonal office South Zonal East Zonal West Zonal North zone (Ghaziabad) Rajasthan Uttarakhand North Delhi 21-03-2024 8

23. Zonal office North Zonal South Zonal West Zonal East zone ( Kolkata) Andaman and Nicobar Arunachal Pradesh Assam Bihar Jharkhand Manipur Meghalaya Mizoram Nagaland Orissa Sikkim Tripura West Bengal 21-03-2024 8

24. Zonal office North Zonal East Zonal West Zonal South zone ( Chennai) Kerala Pondicherry Lakshadweep Tamil Nadu 21-03-2024 8

25. Zonal office North Zonal South Zonal East Zonal West zone ( Mumbai) Chattisgarh Goa Daman & Diu Silvassa Madhya Pradesh Maharashtra 21-03-2024 8

26. Zonal office Additional zonal offices + Ahmadabad + Hyderabad 21-03-2024 8

27. Zonal office Sub-Zonal office 21-03-2024 8

28. Zonal office Sub-Zonal office Bangalore, Varanasi, Goa, Jammu, Indore, Guwahati, Baddi 21-03-2024 8

29. ICH ICH regulate the quality, safety and efficacity of any medical products. No of guideline Guideline purpose Q1A-Q1F Stability Q2 Analytical validation Q3A-Q3D Impurities Q4A-Q4B Pharmacopoeias Q5A-Q5E Quality of Biotechnological Products Q6A-Q6B Specification Q7 Good Manufacturing practices Q8 Pharmaceutical Development Q9 Quality risk management Q10 Pharmaceutical quality system Q11 Development and Manufacture of Drug Substances Q12 Lifecycle management Q13 Continuous Manufacturing of Drug Substances and Drug Products Q14 Analytical Procedure Development 21-03-2024 9

30. ICH No of guideline Guideline purpose S1A-S1C Carcinogenicity Studies S2 Genotoxicity Studies S3A-S3B Toxicokinetic and Pharmacokinetics S4 Toxicity Testing S5 Reproductive Toxicology S6 Biotechnological Products S7A-S7B Pharmacology Studies S8 Immunotoxicology Studies S9 Nonclinical Evaluation for Anticancer Pharmaceuticals S10 Photo safety Evaluation S11 Nonclinical Paediatric Safety S12 Non-clinical Biodistribution Consideration for Gene Therapy Products 21-03-2024 10

31. ICH No of guideline Guideline purpose E1 Clinical safety for drugs used in long term treatment. E2A-E2F Pharmacovigilance E3 Clinical study reports E4 Dose response studies E5 Ethnic factors E6 Good clinical practice E7 Clinical trials in Geriatric Population E8 General considerations for clinical trials E9 Statistical Principals of clinical trials E10 Choice of control group for clinical trials E11-E11A Clinical trials in Pediatric Population E12 Clinical Evaluation by Therapeutic Category E14 Clinical Evaluation E15 Definitions in Pharmacogenomics and Pharmacogenetics E16 Qualifications for gnomic Biomarkers E17 Multi-regional Clinical Trials 21-03-2024 11

32. No of guideline Guideline purpose M1 MedDRA Terminology M2 Electronic Standards M3 Nonclinical Safety Studies M4 Common Technical Document M5 Data elements & Standards for Drug dictionaries M6 Gene Therapy M7 Mutagenic Impurities M8 Electronic common Technical Document M9 Biopharmaceutics Classification System (BCS)-based Biowaivers M10 Bioanalytical method validation and Study Sample Analysis M11 Clinical electronic Structured Harmonised Protocol M12 Drug Interaction Studies M13 Bioequivalence for Immediate-Release Solid Dosage Form M15 General Principles for model informed drug development E18 Genomic sampling methodologies E19 Safety data collection E20 Adaptive Clinic Trials E21 Inclusion of Pregnant and breastfeeding Individuals in Clinical 21-03-2024 12

33. Zone I Zone II Zone III Zone IV ICH WORLD MAP ACCODING TO ZONES Map Temperate zone Sub-tropical zone Tropical dry tropical wet 21-03-2024 13

34. United Kingdom, Northern Europe United states Russia <15˚C / 45% R.H ICH Zone I Map Temperate zone Sub-tropical zone Tropical dry tropical wet 21-03-2024 13

35. Japan South Europe 15-25˚C/ 60% RH ICH Zone II Map Temperate zone Sub-tropical zone Tropical dry tropical wet 21-03-2024 13

36. Australia Argentina Iraq 30˚C/ 35% RH ICH Zone III (Hot and dry) Map Temperate zone Sub-tropical zone Tropical dry tropical wet 21-03-2024 13

37. India Brazil Singapore Indonesia 30˚C/ 65% RH ICH Zone IV (Hot and humid) Map Temperate zone Sub-tropical zone Tropical dry tropical wet 21-03-2024 13

38. REFRENCE:- CDSO Management committee1940, organization,14-octombmer-2023, cdsco.gov.in. S achin Itkar and Dr. N.S. Vyawahare , Drug Regulatory Affairs, 3rev, new Delhi, Nirali Prakashan 87-112. ICH management committee 1990, QSEM, 08-octomber-2023, https://www.ich.org/. 21-03-2024 14

39. T h a n k s ! For your concentration. 21-03-2024 15