WHO and BPOM Guidelines for Dossier Submission - Santi Rismadani.pptx

penjabaran mengenai guidelines WHO untuk dossier submission - vaccine manufacturer

1. WHO and BPOM Guideline for Dossier Submission Santi Rismadani Kelompok Spesialis Pengembangan Infrastruktur dan Harmonisasi Riset PT Bio Farma (Persero) 2023

2. Materi Presentasi A B C

3. Sending an Official Request to WHO Send the application letter form to the Coordinator, Quality, Safety and Standards, Department of Essential Medicines and Health Products in WHO WHO will request to prepare and submit a PSF or an eCTD WHO will acknowledge the official request email, if accepted, WHO will request to prepare and submit a product summary file (PSF) in one hard copy and five electronic copies or an electronic common technical document (CTD). If rejected, WHO will be respond with an "Official Letter" if the vaccine will not be accepted because it is not a priority. In such cases, the applicant and the NRA will be advised of the rejection of the application within two weeks of receipt of the official request. Arrange Pre-Evaluating Meeting A pre-evaluation meeting including representatives of the manufacturer, the responsible NRA and WHO may be scheduled if considered necessary (for discussing programmatic suitability issues) How to Submit Vaccine Prequalification Dossier ? A 1 2 3

4. Sending a copy of the application letter sent to WHO inform the NRA of their application to WHO for the vaccine prequalification by sending to the NRA a copy of the application letter sent to WHO giving details of country and sites of manufacture, licensing status and the presentations put forward to United Nations agencies for procurement. Request the NRA to participate/collaborate in the process Make Discussion with NRA and WHO Representatives provide the NRA with the necessary authorization to discuss the relevant files with WHO representatives. Since reliance on effective regulatory oversight by the National Regulatory Authority (NRA) of the country of manufacture plays a critical role in the system, manufacturers are required to engage with NRAs from the beginning of the prequalification application process (Indonesia’s NRA = BPOM (Badan Pengawas Obat dan Makanan ) Provide The Marketing Authorization Before submitting a product summary file (or common technical document) in application for WHO prequalification, manufacturers must also obtain a "Marketing Authorization" from the responsible NRA. The marketing authorization demonstrates that the NRA has conducted the required regulatory oversight – review and assessment – of the product and grants it a licence to be marketed. 1 3 2 4

5. WHO has established three deadlines per year for eCTD submission: 31 January 31 May and 30 September Deadline for Submission *Any application must arrive at WHO no later than the submission date if it is to be considered for the subsequent round of review. Applications received after the submission deadline will not be considered for evaluation until the following review round.

6. PSF or CTD ? In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States. As of 1 January 2021, all applications for full assessment will be required in CTD format. Manufacturers may now submit their applications in the common technical document (CTD) format, rather than as a PSF, provided that: - a detailed cross-referencing of contents is presented - information required by WHO but not included in the CTD requirements is included.

7. eCTD (electronic Common Technical Document) B As of 1 January 2021, all applications for full assessment will be required in CTD format. PSF = Product Summary File, The PSF provides information on the product composition, manufacturing procedure, testing, stability, labelling, clinical experience and available post-marketing safety information eCTD = electronic Common Technical Document CTD Content : 1. Module 1 (section 1.1, 1.2, 1.3) (section 1.4) (section 1.5) (section 1.6) (section 1.7, dan 1.8) 2. Module 2 : Common Technical Document Summaries (As per ICH guidelines M4Q, M4S, M4E) 3. Module 3 : Quality (as per ICH M4Q) 4. Module 4 : Nonclinical Study Reports (as per ICH M4S) 5. Module 5 : Clinical Study Reports (as per ICH M4E) *Requirement : in English, Ms Word/PDF, Searchable version

8. A. For initial Product Assesment : a PSF or CTD must be submitted for each vaccine to be assessed. B. For combination vaccines : Information must be submitted on each of the component vaccines and on the combination itself. If a combination vaccine is being evaluated and the monovalent versions of the antigens contained in the combination are also being evaluated, the information provided for the monovalent vaccines (up to concentrated bulk) can be used for the assessment of the combinations or, conversely, the information on each antigen provided in the PSF OR CTD of the combination vaccine can be used to assess the monovalent vaccines (up to concentrated bulk level).

9. 1.1 Table of Content 1.2 Correspondence 1.3 Site Master File 1.4 Compliance Information

10. 1.5 Vaccine Composition, Presentations and Scheduling Information 1.6 Suplemental Preclinical and Clinical Information (Pre- and Post Marketing)

11. 1.7 Regulatory Actions 1.8 Distribution Information Module 2 : CTD Summaries (see ICH Guidelines M4Q, M4S, M4E) Module 3 : Quality (see ICH Guideline M4Q) Module 4 : Noncliincal Study Report (as per ICH M4S) Module 5 : Clinical Study Report (see ICH Guideline M4E)

12. ICH (The International Council for Harmonisation C The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. Since its announcement of organisational changes in October 2015, ICH has grown as an organisation and now includes 20 Members and 36 Observers.

13. ICH Guideline Q : Quality Guidelines S : Safety Guidelines E : Efficacy Guidelines M: Multidisciplinary Guidelines - M4: The Common Technical Document

14. M4: The Common Technical Document The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.

15. Source : WHO Guidelines : Dossier Submission https://extranet.who.int/pqweb/vaccines/official-request-response 2. ICH : CTD https://www.ich.org/page/ctd

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