PHARMA KNOWLEDGE PARK

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Briana Anthony
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1 GUIDELINES

2 A COMPILATION BY ON PHARMACEUTICAL REGULATORY GUIDELINES INTRODUCED / REVISED DURING THE YEAR Page 2

3 ICH Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, M7, Current Step 2 version, 6 February Guideline for elemental impurities, Q3D, current step 2b version, 26 July 2013 Page 3

4 WHO Prequalification: WHO guidelines on variations to a prequalified product, Annex 3, WHO Technical Report Series 981, Collaborative procedure between the WHO/PREQUAL programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products, Annex 4, WHO Technical Report Series 981, 2013 WHO guidelines on quality risk management, Annex 2, WHO Technical Report Series 981, 2013 Page 4

5 WHO Release procedure for International Chemical Reference Substances, Annex 1, WHO Technical Report Series 981, Proposal for Revision of the Supplementary Guidelines on Good Manufacturing Practices: Validation, Appendix 7: Non-Sterile Process Validation, April 2013, Draft for comment. General guidance for inspectors on "HOLD-TIME" studies, July 2013, Revised draft for comment. Good Pharmacopoeial practices concept paper on purpose and benefits, May 2013, Draft for comment. Page 5

6 WHO Proposed updated text for WHO GMP for pharmaceutical products: Main principles July 2013, Revised draft for comment. Melting point and melting range (Methods of analysis) for future publication in The International Pharmacopoeia, July 2013, Draft for comment. Proposed text for the supplementary information section of The International Pharmacopoeia: dissolution testing of tablets and capsules, September 2013, Draft for comment. Page 6

7 USFDA Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the ectd Specifications, Draft Guidance, January International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary), M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Draft Guidance, April Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter (PDF - 94KB), Final Guidance, May Page 7

8 USFDA Current Good Manufacturing Practices (CGMPs)/Compliance, Contract Manufacturing Arrangements for Drugs: Quality Agreements, Draft Guidance, May Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Final Guidance, June International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary), M2: ectd Specification Questions & Answers and Change Requests Companion Document, Final Guidance, June ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, Draft Guidance, August Page 8

9 USFDA ANDA Submissions - Refuse-to-Receive Standards, Draft Guidance, September Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1), Draft Guidance, September Q3D Elemental Impurities (PDF - 811KB), Draft Guidance, October Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF - 75KB), Draft Guidance, December Page 9

10 EDQM Certification of suitability to Monographs of the European Pharmacopoeia, Procedures for management of revisions/renewals of certificates of suitability to the European Pharmacopoeia monographs, Public Document (Level 1), July Certification of suitability to Monographs of the European Pharmacopoeia, Guidance for electronic and paper submissions for certificates of Suitability (CEP) applications, Date of Implementation: 1 August Certification of suitability to Monographs of the European Pharmacopoeia, Guidance on applications for «sister files», September Page 10

11 EDQM Certification of suitability to Monographs of the European Pharmacopoeia, Use of CESP to submit electronic documents to EDQM, December Quality Management Document, Qualification of Equipment, Annex 8: Qualification of Balances, December 2013 Page 11

12 EMA Annexes to Specifications for class 1 and class 2 residual solvents in active substances, Rev. 01, Date for coming into operation: 1 March EMA Procedural advice for users of the centralized procedure for generic/hybrid applications, EMEA/CHMP/225411/2006, March European Medicines Agency post-authorization procedural advice for users of the centralized procedure, EMEA-H-19984/03 Rev 37, December Page 12

13 EMA European Medicines Agency pre-authorization procedural advice for users of the centralized procedure, EMA/339324/2007, December European Medicines Agency post-authorization procedural advice for users of the centralized procedure, December Page 13

14 THANK YOU Page 14

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE GUIDELINES INDEX

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE GUIDELINES INDEX BATCH Q: Quality Q1A(R2) Stability Testing of New Drug Substances