Getting Drugs Approved – What you need to know from a GMP Perspective
What is a regulatory Dossier?
- Why do we need regulatory dossiers?
- Why are regulatory dossiers binding?
Drug Approvals in the ICH countries: Prerequisites and Procedures
- Centralized procedure / Decentralized procedure
- Mutual Recognition
- National Procedures
- Specific Dossier Requirements for different Medicinal Products
- Time Lines
- Generic Applications
- New Drug Application (NDA)
- IND procedure and special issues
- Abbreviated New Drug Application (ANDA) – Generics
- Pre-approval inspections
- Timelines and meetings with the FDA
- Regulatory Requirements in Japan
- GMP Regulations in Japan (J-GMP)
CTD Module 1- Summary of Product Characteristics and other national Requirements
- Quality related aspects of the SmPC
- Clinical particulars
- Pharmacological properties
- Pharmaceutical particulars
- Labelling
- Package Leaflet
- Mock ups and Specimen
- Quality Experts, Non Clinical and Clinical Experts
- Bibliographical applications
- Homeopathic Applications
- Pediatric Applications
CTD Module 2- The Quality Overall Summary: Importance and Benefits
- Regulatory background of QOS
- Benefits (and why you can call it „Queen of Submission“)
- Frequent deficiencies, examples
- Optimising the submission
CTD Module 3 – Quality of the Drug Product: relevant GMP Documents
- Medicinal product – documentation of quality in Module 3
- Impurities
- Stability data
- Container and closure systems
- Critical parameters
- Optimising the submission
- Risk based approach in industry and regulatory authority
CTD Module 3- How to document Drug Substance Quality – Certificate of Suitability (CEP) and Active Substance Master File (ASMF)
- Documentation of drug substance quality in Module 2
- The Quality Overall Summary (QOS)
- CEP and ASMF procedure – how they work in principle
- Types and format of ASMFs
- Contents of the applicants part and the restricted part
- How to apply for a CEP
- Dossier Content
- CEP assessment and CEP inspections
- DMF procedures in US and Japan
CTD Modules 4 and 5- non clinical and clinical Documentation: GMP, GCP and GLP Aspects
- Clinical study reports
- Efficacy and safety
- Clinical summary and clinical overview
- Non clinical study reports
- Toxicology
- Pharmacokinetics
- Safety studies – decision tree
- Toxicity studies to qualify impurities
- Non clinical summary
- Critical points
Regulatory Compliance Aspects during Authority Inspections
- Types of inspections
- Essential PQS interfaces
- Change control from a GMP view
- Deviations from Marketing Authorisations
- Inspector’s planning, preparation, conduction and follow-up of GMP inspections
Technical Terms of GMP Inspections – EU-GMP Requirements
- EU-GMP regulations
- Technical terms of EU-GMP guidelines
- Basic requirements for GMP inspections
Maintaining a Marketing Authorisation – The Interaction between GMP and Regulatory Affairs
Handling Changes in the ICH countries
- Starting a change in your company
- The variations procedure in Europe
- General provisions of the Commission Regulation (EC) No 1234/2008
- Supporting Guidelines
- Best Practice Guides and Explanatory Notes
- Classification of variations
- Procedural handling of variations; Grouping, Worksharing
- Handling Changes in the US: Changes to an approved NDA and ANDA
- Types of changes
- Change control procedure and reporting mechanisms
- Handling changes in Japan: Change procedures and communication with the Japanese authority
- Types of changes
- Notification of changes