Introduction to Pharma Regulatory Affairs

It constitutes of basic introduction of regulatory affairs in pharmaceuticals, career in pharma regulatory affairs, job opportunities and future aspect. GIBTIndia offers job oriented e- learning courses. Kindly visit us at www.gibtindia.com

Transcript

1. Global Institute of Biosciences and Technology
2. What is regulatory affairs? Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs in the pharma industry may be defined as "The interface between the pharmaceutical company and the regulatory agencies across the world.“ Regulatory Agencies Regulatory Affairs Department Department A Department B Department C Department D Pharmaceutical Company GIBT INDIA
3. Role of RA  To keep track of the ever changing legislation  Registration documents to regulatory agencies  To give strategic and technical advice to R&D, Production, QC Department etc. GIBT INDIA
4. What does a DRA department required in a Pharmaceutical organization?  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 15years 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 the number of development failures. GIBT INDIA
5. Which departments are assisted by DRA Department? Drug Regulatory Authorities (across the world)  CDSCO- India  USFDA- United States  EMEA- European countries  MHRA- United Kingdom  TGA- Australia  MCC- South Africa Internal Departments of Organizations  Product Developments  Clinical Research & Trials  Licensing  Manufacturing  Quality Assurance & Control  Marketing GIBT INDIA
6. On what issues does DRA department provide assistance?  Licensing  Registration  Development  Manufacturing  Quality Guidance  Pricing  Marketing  Pharmacovigilance  GMP  GLP  GCP  Patent  Copyright  Trademark ………..& many more GIBT INDIA
7. You should know  What is Dossier?  What is DMF?  What is CTD / eCTD?  What is NDA / ANDA or MAA? GIBT INDIA
8. What is Dossier? Dossier is a collection or file of documents that contain all the technical data of pharmaceutical product to be approved / registered / marketed in a country. It is most commonly called as Registration Dossier, In US: New Drug Application (NDA) In EU: Marketing Authorization Appliation (MAA) GIBT INDIA
9. What is DMF? Drug Master File (DMF) Type I- Mfg. sites, Facilities, Operating Procedures and Personnel (no longer applicable) Type II- DS, Intermediate and material used in their preparation or drug product Type III- Packaging Material Type IV- Excipient, Colorant, Flavor or Material used in their preparation Type V- FDA Accepted Reference Information (FDA discourages its use) US United State Drug Master File (US- DMF) EU European Drug Master File (EDMF) or Active Substance Master File (ASMF) GIBT INDIA
10. What is CTD / eCTD? Common Technical Document (CTD), It is an format set by ICH which was agreed by Regulatory Agencies of Europe, Japan and the US. Its electronic version called as electronic Common Technical Document (eCTD) GIBT INDIA
11. GIBT INDIA
12. For USA Application formm 356h Proposed label Patent Certification /Information Debarment Certificate Letter of Authorization (LOA)/DMF Letter Labeling Text For EU Application form Summary of product characteristics Labelling text andmock-ups Information about the experts Environmental riskassesment Description of the pharmacovigilance system Risk management plan Module 1 Administrative Information(Region Specific) Should contain documents specific to each region GIBT INDIA
13. Module 2 CTD Summaries (QOS)  It contains 7 Sections in the following order:  CTD DOC (Module 2- 5)  CD Introduction  Quality Overall Summary  Non- Clinical Overview  Clinical Overview  Non Clinical Summary  Clinical Summary GIBT INDIA
14. Module 3 Quality (CMC)  TOC of Module 3  Body of Data a) Drug Substance b) Drug Product c) Appendices d) Regional Information  Literature References GIBT INDIA
15. Module 4 Non- Clinical Study Report:  TOC of Module 4  Study Reports a) Pharmacology b) Pharmacokinetics c) Toxicology  Literature References GIBT INDIA
16. Module 5 Clinical Study Reports  TOC of Module 5  Tabular listing of Clinical Studies  Clinical study reports a) Reports of Biopharmaceutical (BA-BE) Study b) Reports of Pharmacokinetic (biomaterial) study c) Reports of Pharmacokinetic (PK) Studies d) Reports of Pharmacodynamic (PD) Studies e) Reports of Efficacy and Safety studies f) Reports of Post – Marketing experience g) Case Report Forms & Individual patient listings  Literature References GIBT INDIA
17. eCTD Its electronic version of CTD, so called as electronic Common Technical Document (eCTD).  eCTD composed of two types of specification a) Content Specification- As defined by ICH b) Technical Specification- Electronic software’s CTDTOC (PDF) (Paper) eCTD XML Backbone GIBT INDIA
18.  eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing  From year 2019 European Union also make compulsory for electronic CTD submission to all procedures GIBT INDIA
19. eCTD Characteristics Structure  All modules 1 to 5have granularity options  PDF documents linked via XML backbone  Increased document granularity  Transparency of entire submission  Ease of navigation and review GIBT INDIA
20. Benefits of eCTD GIBT INDIA