STABILITY REGULATIONS and GUIDANCES

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1 STABILITY REGULATIONS and GUIDANCES John O Neill MS, RPh Stability Information Specialist, Nagano Science Ltd KENX Laboratory University - Stability Philadelphia PA June 17-19, 2019

2 HOW MANY ARE THERE?

3 HOW MANY ARE THERE? It Depends What category, what level, do you count annexes, Q&A s, briefings, trainings, Notes for Guidance, all categories of medical products, etc.? You can easily reach several hundred.

4 REGULATIONS and GUIDANCES Why two categories? What s in them? What s not in them? Why so many sources? What if we don t follow them?

5 WHY TWO CATEGORIES? Best explained with traffic signs Which are mandatory and carry legal penalties and which are helpful information?

6 Regulations Laws enacted by governmental authorities Provide high level requirements with latitude for implementation Stringent direct consequences for non-compliance Guidances Recommendations through national and regional agencies/bodies Relatively specific prescribed practices to fulfill legal requirements Indirect consequences (still stringent) for non-conformance

7 EXAMPLE STATEMENT ON GUIDANCES FROM HEALTH CANADA Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

8 REGULATORY ROUTES

9 Local Ordinance (County Fire Code - Sprinklers in Stability Chambers) State Regulation (Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing or retailing drugs, medical devices, and/or medicated cosmetics must register with the Department of Health unless otherwise noted as a designated exemption) Federal Regulations (CFR ) Stability Testing International Guidances (ICH Q1A R2) Stability Testing of New Drug Substances and Products

10 MULTI-NATIONAL / AREA GUIDANCES

11 MULTI-NATIONAL / AREA GUIDANCES Example ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT 1.2 In principle, stability testing should be biased towards more stressful rather than less stressful conditions so as to provide a margin of error in favour of the patients and to increase the likelihood of identifying substances or formulations that pose particular stability problems. 1.5 The general conditions for long term stability testing in the ASEAN region are the Zone IVb conditions (30⁰ C/75% RH).

12 CHANGING THE RULES

13 CHANGING THE RULES Subtract Nothing from a Regulation Fulfill them with Guidances and Best Practices Go beyond them if it suits you Deviate from them at your own peril Even when the Guidance states you may deviate, severe consequences may result

14 REGULATIONS and GUIDANCES WON T TELL YOU THE WHY

15 REGS and GUIDES WON T TELL YOU THE WHY The Whys come from adverse events, regulatory citations, frustrations of Reviewers and the personal biases of hundreds of law-makers and committee members who put together regulations and guidances and then keep them up to date and moving forward with the advancement of technology and practices. When you want to know why why is not in the document, consider how long that would make the document. In some cases, a companion Q&A document is issued to address previously unexplained issues.

16 ENFORCEMENT Consider who shows up for this and who shows up for that

17 ENFORCEMENT The penalty is related to the infraction.

18 ENFORCEMENT 483 Observation Warning Letter Consent Decree Import Alerts & Refusal Seizure Fines Injunction Criminal Prosecution

19 SOME NATURAL CONSEQUENCES FAR OUTWEIGH LEGAL CONSEQUENCES

20 SOME NATURAL CONSEQUENCES FAR OUTWEIGH LEGAL CONSEQUENCES Damage to Public and Regulatory Reputation Delayed Time to Market Loss of Potential Sales and Market Share Loss of Investor Confidence Loss of Contracts

21 WHEN MULTIPLE REGS and GUIDES CONFLICT

22 WHEN MULTIPLE REGS and GUIDES CONFLICT Consider your target Marketing Area Comply with the strictest of regulations/guidances for the same topic Consult your national regulatory agency Prepare a justification for your action that withstands scrutiny from several disciplines Document your course of action Prepare a Story Board in preparation for questions by inspectors and reviewers

23 HOW IMPORTANT ARE FOREIGN REGULATIONS?

24 HOW IMPORTANT ARE FOREIGN REGULATIONS? What do you have at stake? Will someone else get to the foreign market first? How important is your regulatory reputation in that country? Will other countries easily follow if you succeed with one country in their region? Should you invest in having local respondents on your staff (language & regulatory ability)

25 NATIONAL REGULATIONS

26 NATIONAL REGULATIONS Some nations lead the way in advancing science while others are driven by national pride. Nations to watch: Brasil China Russia Japan

27 BRAZILIAN HEALTH REGULATORY AGENCY ANVISA API Registration Department COIFAHTTPS://WWW20.ANVISA.GOV.BR/COIFAENG/FAQ.HTML 3.2.S.7.1 If a drug product is manufactured in Europe and imported to Brazil, should the long term API stability study be conducted at 30ºC/75%RH (Zone IVb)? The condition for the stability study of the API should be the most critical among the stability zones of the countries in which the API is manufactured/stored prior to the manufacture of the drug product. For example: Drug product manufactured in Brazil (regardless of where the API is manufactured) API stability study: 30ºC/75%RH; API manufactured in Europe + drug product manufactured in Europe and imported to Brazil API stability study: 25ºC/60%RH or stricter; API manufactured in China + drug product manufactured in Europe and imported to Brazil API stability study: 30ºC/65%RH or stricter; API manufactured in India + drug product manufactured in Europe and imported to Brazil API stability study: 30ºC/70%RH or stricter. Stability conditions for WHO Member States by Region. These concepts do no apply if the storage condition of the API is 2/8ºC or -25ºC/-15ºC.

28 THE ICH SERIES (International Conference on Harmonisation) 1989 Harmonization talks begin; Europe, Japan, and United States (Industry & Regulatory Agencies) 1990 The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created at a meeting in Brussels ICH steady evolution to a more global initiative; now constituted by 16 Members and 28 Observers; newest Regulatory Observer NRA, Iran. Current 25 Working Groups which involve over 600 experts

29 THE ICH SERIES (International Conference on Harmonisation) Future strategic areas for harmonization by ICH: Standards for Generic Drugs Advancing Pharmaceutical Quality Standards Technical Scientific Requirements for Pharmacoepidemiological Studies Submitted to Regulatory Agencies to Advance More Effective Utilization of Real-World Data.

30 THE ICH SERIES (International Conference on Harmonisation) First Major Regional Guidance Succeeded on momentum of major industry and regulatory areas Motivation to smooth the way to the big markets by agreeing on common requirements Didn t have to cover the whole world (WHO did, but had little clout) Was not originally an ongoing effort

31 THE ICH SERIES (International Conference on Harmonisation) A few drawbacks: A bit assumptive Rest Of World did not automatically subscribe Zone 4 Definition - a major point of contention

32 THE ICH SERIES (International Conference on Harmonisation) Q1A (R2) Stability Testing of New Drug Substances and Products Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products Q1B Photostability Testing of Stability Testing of New Drug Substances and Products Q1C Stability Testing of New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E Evaluation for Stability Data Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV (withdrawn) Q2 (R1 Validation of Analytical Procedures: Text and Methodology

33 THE ICH SERIES (continued) Q3A (R2) Impurities in New Drug Substances Q3B (R2) Impurities in New Drug Products Q3C (R6) Impurities: Guideline for Residual Solvents Q3C (R7) Impurities: Guideline for Residual Solvents (revision of R6 in progress for 3 new solvents) Q3D Guideline for Elemental Impurities Q3D (R1) Guideline for Elemental Impurities Q3D (R2) Guideline for Elemental Impurities Final Concept Paper 2016 ICH Q3D Final Concept Paper Q3D: Elemental Impurities IWG ICHQ3D Training; Implementation of Guideline for Elemental Impurities ICH Q4-Q4B Pharmacopoeias ICH Q5C Stability Testing of Biotechnological/Biological Products ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (see section for Stability section) ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New DS and DP Chemical Substances Decision Trees for Q6A ICH Q6B Specifications: Test Procedures and Application Criteria for Biotechnical/Biological Products

34 THE ICH SERIES (continued) ICH Q7 Good Manufacturing Guide for Active Pharmaceutical Ingredients Q&A on ICH Q7 Good Manufacturing Practice Questions and Answers Document ICH Q8 Pharmaceutical Development Q8, Q9, Q10 Training Program ICH Q9 Quality Risk Management Q9 Briefing Pack ICH Q10 Pharmaceutical Quality System Q10 Briefing Presentation ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotech/Biological Entities Questions and Answers for Q11 Development and Manufacture of Drug Substances ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management ICH Q12 Annex for Tech and Regulatory Considerations for Pharmaceutical Product Life Cycle Management

35 THE ICH SERIES (continued) Q13 revision of ICH Q2(R1) Guideline on Validation of Analytical Procedures: Text and Methodology intended that the new guidelines will be consistent with ICH Q8(R2), Q9, Q10, Q11 and Q12. Q14 Quality by Design Q15 Stayed tuned; under discussion

36 ICH Q1A-F THE FDA SERIES ANDA Submissions Amendments and Requests for Final Approval to Tentatively Approved ANDAs ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers- JANUARY 2019 Stability Testing of New Veterinary Drug Substances Stability Requirements - Licensed In Vitro Diagnostic Products Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry

37 THE FDA SERIES Changes to an Approved NDA or ANDA: Questions and Answers MISCELLANEOUS CHANGES Q1: The guidance recommends an annual report for the addition of time points to the stability protocol or deletion of time points beyond the approved expiration dating period. If these changes are made in an annual report, is the protocol still considered approved? A1: Yes. If changes such as these are made in an annual report, the stability protocol is still considered approved. Q2: How should the addition of a test to an approved stability protocol be reported? A2: When a test is added, whether it is added to a release specification or a stability protocol, the change should be reported in a Supplement Changes Being Effected under section VIII.C.2.a of the guidance, which states "An addition to a specification that provides increased assurance that the drug substance or drug product will have the characteristics of identity, strength, purity, or potency that it purports or is represented to possess. For example, adding a new test and associated analytical procedure and acceptance criterion."

38 THE EMA SERIES European Medicines Agency EudraLex Vol 4. Good manufacturing practice (GMP) Guidelines. European Commission ICH Q1A-F Declaration of storage conditions for medicinal products particulars and active substances (Annex) In-use stability testing of human medicinal products Maximum shelf-life for sterile products for human use after first opening or following reconstitution Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) Stability testing for applications for variations to marketing authorization Stability testing of existing active ingredients and related finished products

39 THE WHO SERIES Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products Annex 4 General guidance on hold-time studies Guidelines for registration of fixed-dose combination medicinal products. Apdx 3 Pharmaceutical development (or preformulation) studies. Table A1: Typical stress conditions in preformulation stability studies. Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

40 REGIONALS Association of South East Asian Nations (ASEAN) ANNEX V ASEAN GUIDELINES ON STABILITY STUDY AND SHELF- LIFE OF TRADITIONAL MEDICINES Middle Eastern Zone 3 & 4 Nations (via World Health Organization) Report on the Consultation on Regional Guidelines on Stability Studies of Medicines and Biologicals

41 NATIONALS Medicines Control Council Republic of South Africa Registration of Medicines- Stability Health Canada: Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) Sections S7 & P8 Brasil ANVISA stability studies regulations RE Nr. 1 (Guia Para a Realizacao de Estudo de Estabilidade-Portuguese*) & RDC Nr. 45. RDC Nr. 45 [1,2] /2012 (API stability studies - English) * %20english%20%201%20aug% pdf Saudi Arabia The GCC Guidelines for Stability Testing of Drug Substances and Pharma Products China Food and Drug Administration (CFDA) Director executed 2007

42 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE General Consumer Goods Pharmaceuticals EUDRALEX The Rules Governing Medicinal Products in the European Union EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Principles of Good Distribution Practice of active substances for medicinal products Chapt. 5 section 5.1 Monitoring devices that are necessary to guarantee the quality attributes of the active substance should be calibrated according to an approved schedule against certified traceable standards.

43 THE EUROPEAN MEDICINES AGENCY SERIES ICH Q1A-F Declaration of storage conditions for medicinal products particulars and active substances (Annex) Annex 19 Reference and Retention Samples In-use stability testing of human medicinal products Maximum shelf-life for sterile products for human use after first opening or following reconstitution Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) Stability testing for applications for variations to marketing authorization Stability testing of existing active ingredients and related finished products

44 WHAT IF THERE SEEMS TO BE NO WAY FORWARD?

45 WHEN THERE SEEMS TO BE NO WAY FORWARD The European Medicines Agency Questions and Answers related to the United Kingdom s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure Rev 04, 1 February 2019

46 WHEN THERE SEEMS TO BE NO WAY FORWARD Consult national and regional authorities Check with Industry Associations and Discussion Groups Go above and beyond with justifications for your best good faith effort

47 SUMMARY There are lots and levels of Stability Regulations and Guidances Choose your Target Market and Zones Employ full-time Stability Intelligence Identify issues that could prove difficult Strategize and develop sound justifications where you have to improvise

48 Your thoughts, comments, and questions

49 Thank you, and

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