Additional resources

Additional resources

 Additional resources 

	The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) http://www.ich.org/

4. International Council on Harmonisation (ICH)

Jump to... Jump to... 1. Medicines regulation - ensuring effective medicines with acceptable risk 2. Legislative documents governing medicines regulation 3. Stakeholders in the development of medicines legislation in the EU 3.1 The European network in medicines regulation – National Competent Authorities (NCAs) 4. Guideline development in the EU 4.1 Implementation and status of CHMP guidelines 1. The global perspectives in medicines development 2. Medicines regulation and collaboration at the global level 3. World Health Organisation (WHO) 4. International Council on Harmonisation (ICH) 1. Background and general principles of the regulatory approval of medicines 2. Benefit-risk assessment 3. Fulfilling medicines regulation during approval process in the EU 4. Patients’ involvement in medicines regulation at the EMA 5. Benefit-risk evaluation at the time of approval 6. Cost-effectiveness evaluation post approval 7. Benefit-risk of medicines post approval 8. Tools in benefit-risk evaluation of medicines 9. Patients’ views and involvement in benefit-risk evaluation 1. History of pharmacopoeias 2. Role of modern pharmacopoeias 2.1. Impurities controlled by EP monographs 3. Roles of the European Directorate for the Quality of Medicines (EDQM) and the European Pharmacopoeia (EP) Commission in the medicines regulations system 1. Introduction 2. About Good 'x' Practice (GxP) 3. Key GxPs in Medicine 4. Pharmaceutical Quality System (PQS) 5. Examples of GxPs (non-comprehensive list) Assessment

1. Background and general principles of the regulatory approval of medicines