Introduction to Pharma regulatory affairs

Introduction to Pharma regulatory affairs

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  Global Institute of Biosciencesand Technology
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  What is regulatoryaffairs? 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
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  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
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  What does aDRA 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
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  Which departments areassisted 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
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  On what issuesdoes DRA department provide assistance?  Licensing  Registration  Development  Manufacturing  Quality Guidance  Pricing  Marketing  Pharmacovigilance  GMP  GLP  GCP  Patent  Copyright  Trademark ………..& many more GIBT INDIA
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  You should know What is Dossier?  What is DMF?  What is CTD / eCTD?  What is NDA / ANDA or MAA? GIBT INDIA
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  What is Dossier? Dossieris 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
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  What is DMF? DrugMaster 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
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  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
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  GIBT INDIA
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  For USA Application formm356h 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
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  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
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  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
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  Module 4 Non- ClinicalStudy Report:  TOC of Module 4  Study Reports a) Pharmacology b) Pharmacokinetics c) Toxicology  Literature References GIBT INDIA
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  Module 5 Clinical StudyReports  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
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  eCTD Its electronic versionof 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 CTD TOC (PDF) (Paper) eCTD XML Backbone GIBT INDIA
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   eCTD ishighly 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
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  eCTD Characteristics Structure  Allmodules 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
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  Benefits of eCTD GIBTINDIA