English — ODG/RAHC/GDL/001 Rev_.3 official text

GUIDELINES ON RELIANCE FOR REGULATORY DECISION- MAKING FEBRUARY, 2024 Doc. No: ODG/RAHC/GDL/001 Rev_.3 FOREWORD Rwanda Food and Drugs Authority (Rwanda FDA) is a regulatory body established by the Law N° 003/2018 of 09/02/2018. One of the missions of the Authority is to build cooperation and partnership for harmonization of practices with regional and international bodies with similar missions as stipulated in article 8, paragraph 15 of the above stated law. Considering the provisions of the technical regulations No DFAR/HMDAR/TRG/001 governing the registration of medicinal products, regulations No CBD/TRG/011 governing control of medicated cosmetics; Regulations No DFAR/HMDAR/TRG/002, governing Registration of Medical Devices including In Vitro Diagnostics, Regulations No CBD/TRG/013, governing the registration of pesticides, laboratory and cleaning chemicals; regulations No FDISM/PVSM/TRG/001 governing the conduct and Inspection of Clinical Trials in Rwanda, regulations No CBD/TRG/016, governing pharmacovigilance of pharmaceutical products and medical devices, and other relevant regulations, the Authority may rely on regulatory decisions from other regional and international regulatory authorities when deemed necessary. The Authority has developed guidelines No ODG/RAHC/GDL/001 on reliance for regulatory decision-making to promote a more efficient approach for regulatory oversight, access to quality- assured, effective and safe medical products. The reliance is an alternative /non-routine authorization pathway to the standard approval pathways - especially for applications where the safety and efficacy of the product have already been confirmed or when the Clinical Trial has been approved and/or initiated in a well–resourced regulatory authority (ies). The reliance implies that the work done through Clinical Trial Assessment reports, Marketing Authorization (MA) assessment reports, GMP inspection reports, and Quality Control (QC) related decisions is shared by the regulatory authority while the Authority uses this work according to its own scientific knowledge and regulatory procedures and retains its own regulatory responsibilities. The reliance can be unilateral, bilateral (mutual) or multilateral for the regulatory decision but the authority maintains its own regulatory responsibilities for decision-making The Authority acknowledges all the efforts of key stakeholders who participated in the development and validation of these guidelines. Digitally signed by Rwanda FDA (Director General) Prof. Emile BIENVENU Date: 2024.02.14 08:56:59 Director General +02'00' DOCUMENT DEVELOPMENT HISTORY First issue date 14/06/2021 Effective date of this revision 23/02/2024 DOCUMENT REVISION HISTORY Revision Changes made and/or reasons for revision number Rev_0 First issued Rev_1 Revision of section 6.1. Marketing Authorization of medical products by including a statement that capture all ICH members Rev_2 1. ICH founding regulatory member state or region such as European Commission (EMA), United States (United States Food and Drugs Administration), Japan (MHLW/PMDA) or an ICH standing regulatory member state or region such as Canada (Health Canada), Switzerland (Swissmedic) countries were replaced by WHO Transitional listed authorities which includes also all countries which have attained ML3 or 4. 2. New Reference number assigned according to the new requirements of Document Control Revision 3. General rewarding of the whole document was effected Rev_3 Revision of section 5.1 and 5.2, Marketing Authorization of medical products and GMP inspection respectively, by including the list of agencies recognized by the Authority for Reliance TABLE OF CONTENTS FOREWORD .......................................................................................................................................2 DOCUMENT DEVELOPMENT HISTORY ......................................................................................3 DOCUMENT REVISION HISTORY .................................................................................................3 TABLE OF CONTENTS ....................................................................................................................4 ACCRONYMS AND ABBREVIATIONS .........................................................................................5 GLOSSARY ........................................................................................................................................6 1. INTRODUCTION ........................................................................................................................8 2. SCOPE..........................................................................................................................................8 3. PRINCIPLES OF RELIANCE .....................................................................................................8 4. RELIANCE PATHWAYS TO FACILITATE REGULATORY DECISIONS...........................9 5. AREAS OF RELIANCE FOR REGULATORY DECISION ...................................................10 5.1. Marketing Authorization of medical products ....................................................................10 5.2. GMP Inspections .................................................................................................................11 5.3. Vigilance .............................................................................................................................11 5.4. Clinical Trials ......................................................................................................................12 5.5. Quality Control (QC) Testing .............................................................................................12 5.6. Market surveillance and control ..........................................................................................12 6. RELIANCE PROCEDURES .....................................................................................................12 6.1. Verification of Documentations ..........................................................................................12 6.2. Reliance Documentations ...................................................................................................13 6.3. Assessment based on reliance procedures ..........................................................................13 REFERENCES ..................................................................................................................................13 ENDORSEMENT OF THE GUIDELINES ......................................................................................14 ACCRONYMS AND ABBREVIATIONS AVAREF: African Vaccine Regulatory Forum CRO: Contract Research Organizations EAC: East African Community EC: European Commission EMA: European Medicines Authority EU: European Union GMP/GCP: Good Manufacturing Practices/ Good Clinical Practices ICH: International Council on Harmonization of Technical Requirements for ILAC: International Laboratory Accreditation Cooperation. ISO/IEC: International Organization for Standardization and the International Electrotechnical Commission MA: Marketing Authorization, MAGHP: Marketing Authorization for Global Health Products Medical Devices Agency of Japan MHLW/PMDA: Ministry of Health, Labour and Welfare/ Pharmaceuticals and Medical Devices Agency. QC: Quality Control USFDA: United States Food and Drug Administration WHO PQ: World Health Organization Prequalification GLOSSARY In these guidelines, unless the context states otherwise: Abridged regulatory pathways: Abridged regulatory pathways are regulatory procedures facilitated by the use of reliance, whereby the regulatory decision is solely or partially based on the application of reliance. The expectation is that the use of reliance would save resources and shorten the timelines compared to the standard pathways while ensuring that the standards for regulatory oversight are maintained. Authority refers to Rwanda Food and Drugs Authority or Rwanda FDA Competency: Reliance requires that national authorities build the necessary competencies for critical decision making for proper implementation. In most cases, they need to have a number of critical tools for implementation, whether information sharing arrangements or information platforms among others. Conversely, authorities being relied on should have and maintain competencies and performance in the given area and prove the use of internationally accepted standards. The competencies should be bench-marked by transparent processes that develop trust in the capacities of these reference authorities. Consistency: Reliance on a specific process/evaluation/ decision should be established for the specific and well- defined category of products/ practices and should as well be predictable. Thus, it is expected that reliance shall be applied consistently for all products/practices in the same predetermined category. Joint activity is a form of work-sharing whereby a regulatory task is conducted by two or more regulatory Authorities in collaboration in order to share their assessments, benefit from each other’s expertise and discuss any shortcomings of the data being evaluated. For example, a joint assessment is a procedure in which the same application is simultaneously submitted to two or more regulatory Authorities for the (assigned) regulatory Authority is to conduct their evaluations in parallel and share their respective scientific assessments with each other (e.g., the different modules for quality, nonclinical and clinical data can be assigned to different regulatory Authorities for review). The regulatory Authorities participating in the joint assessment can combine their list of questions or deficiencies to send to the manufacturer and base their respective independent regulatory decision on the outcome of these assessments. Similarly, a joint inspection is an inspection involving two or more regulatory Authorities sharing the activities and assessment performed during an inspection. Legal basis: Reliance should be coherent with national legal frameworks and supported by clear mandates/regulations that aim at efficient implementation. Regulatory reliance: Regulatory reliance is the act whereby the regulatory Authority in one jurisdiction may take into account and give significant weight to regulatory work performed by another regulatory or trusted institution for purposes of reaching its own regulatory decisions. Recognition: The recognition is a routine acceptance of the regulatory decision of another regulator or other trusted institution. Recognition indicates that evidence of conformity with the regulatory requirements of a recognized Authority is sufficient to meet the regulatory requirements of Rwanda FDA. Recognition may be unilateral or mutual and may, in the latter case, be the subject of a mutual recognition agreement. Sameness of product: For the purpose of this document, the sameness of product means that two products have identical essential characteristics (i.e., the product being submitted to the relying authority and the product approved by the reference regulatory authority). All relevant aspects applicable to medicinal products, medical devices and in vitro diagnostics have to be considered in order to confirm that the product is the same or sufficiently similar (e.g., same qualitative and quantitative composition, same strength, same pharmaceutical form, same intended use, same manufacturing process, same active pharmaceutical ingredient suppliers, etc.). Additionally, the results of supporting studies of safety, efficacy and quality, indications and conditions of use should be the same. Sovereignty: Reliance should be a sovereign decision. National authorities should decide if they want to use reliance, on which they are going to rely and how. Transparency: Reliance processes should be transparent regarding standards and processes. In addition, the basis/rationale for relying on a specific entity should be disclosed and understood by all parties. Reference Regulatory Authority: In these guidelines, a Reference Regulatory Authority refers to a national, regional or international authority or a trusted institution such as WHO prequalification (WHO PQ) and WHO transitional Listed Authorities (WLA) whose regulatory decisions and/or regulatory work products are relied upon by another regulatory authority to inform its own regulatory decisions. Work-sharing: Work sharing is a process by which the regulatory Authority of two or more jurisdictions shares activities to accomplish a specific regulatory task. The opportunities for work-sharing include, but are not limited to, jointly assessing applications for authorization of clinical trials, marketing authorizations or good practices in inspections, joint work in the post-marketing surveillance of medical product quality and safety, joint development of technical guidelines or regulatory standards, and collaboration on information platforms and technology.