The Product Registration Toolkit is a digital collection of adaptable resources to guide the process of registering health products, like contraceptives, in low- and middle-income countries. The resources include an introductory video, a primer on product registration basics, and a selection of checklists, templates, and decision trees to help you navigate the product registration process from start to finish.
Accelerating Market Entry for Health Products: Tools to Facilitate Regulatory Approval
This 2-minute video provides an overview of the toolkit. To watch this video in French, click here.
Toolkit Documents and Templates
1. Product Registration Basics for Global Health Program Managers
The goal of this guide is to demystify regulatory affairs for non-experts. Readers will learn the basics of product registration and how this information can support good decision-making by program managers in consultation with regulatory experts.
2. Preparing for a Regulatory Submission in a Low- or Middle-Income Country Checklist
Knowing how to start preparing for a regulatory submission can be a daunting task, so let this checklist guide you through the essential steps in the process. From establishing your product strategy and conducting a regulatory landscape analysis through identifying the application submission process, you’ll be prepared to hit the ground running with your own registration.
3. Regulatory Pathway Decision Tree
Several potential regulatory pathways may be open to you for your product registration, including: (1) working toward WHO PQ or leveraging one of the WHO collaborative procedures; (2) making use of one of the regional harmonization mechanisms; or (3) applying for country-level registration directly. Use this decision tree to help you identify which regulatory pathway makes the most sense for you.
4. Regulatory Landscape Assessment Checklist
The regulatory landscape assessment is a critical first step in preparing for product registration to ensure that you are building your application using the most current guidelines and input from local stakeholders and/or authorities. This checklist will provide you with a list of the essential regulatory information to consider when conducting your own landscape assessment.
5. Quality Management Systems Assessment Checklist for New Manufacturers
Conducting a Quality Management Systems Assessment is important for gathering relevant information to confirm the Good Manufacturing Practice (GMP) compliance of your product’s manufacturing facilities. This checklist will provide you with a list of the essential quality information to consider when conducting your own assessment.
6. Dossier Gap Analysis Template
An important first step in preparing a pharmaceutical product dossier for a registration application is ensuring that it aligns with the guidelines of the country where you’re submitting it. This template provides the ICH CTD dossier requirements for a pharmaceutical product and can be adapted to add the Module 1 specific administrative requirements for your targeted submission country. If your target country does not follow the ICH CTD format, you can replace the requirements with country-specific requirements for the gap analysis.
7. Authentication Flow Chart
Determining what type of certification is required for your regulatory documents can be a complicated process. This flow chart will help you identify when to follow the apostille vs legalization process for document authentication.
8. Cover Letter Template
A cover letter is a common document required for a registration application and is typically one of the first pages of the application. This template can be adapted to your specific needs.
9. GMP Invitation Letter Template
A GMP invitation letter is a common document required for a registration application. This letter invites the regulatory authority in the country where registration is sought to visit the manufacturing site to conduct a GMP inspection. This template can be adapted to your specific needs.
10. Letter of Authorization Template
A Letter of Authorization is a common document required for a registration application. This letter is often prepared by the manufacturer or applicant and authorizes the local distributor to provide services on behalf of the applicant such as registering, importing, commercializing, distributing, or selling the product. This template can be adapted to your specific needs.
11. Power of Attorney Template
A Power of Attorney is a legal document that may be required when the applicant needs to transfer legal authority to a local technical representative or marketing authorization holder in the country of registration submission to act on behalf of the applicant. If this is required, you will need to seek legal advice on the preparation of the document. This template is intended to illustrate what you can expect a Power of Attorney to look like.
12. Letter of Access Template
A Letter of Access is a document that may be required for a registration application if there are restricted portions of the Active Pharmaceutical Ingredient Master File or Drug Master File that have been withheld from the application. The Letter of Access grants the authorized party the ability to incorporate information into the application by reference and not by direct disclosure. It also gives the regulatory authority the right to access the restricted information, if necessary, as well as the assurance that if any restricted information changes, the regulatory authority will be notified. This template can be adapted to your specific needs.
13. Application Tracker Template
Regulatory applications often have many moving parts. This application tracker will help you to keep track of the preparation, review, and approval processes for your application.
14. Post-Approval Regulatory Lifecycle Management Checklist
Congratulations! Your product has received Marketing Authorization Approval. But your work is not done. You will likely be responsible for submitting post-approval variations, filing retention and renewal applications, tracking pharmacovigilance, and preparing annual reports. This checklist will help you to prepare for what to expect after your product has been approved.
15. Artwork and Samples Preparation Checklist
The preparation of product artwork and samples is an essential component of bringing a product to market. The regulatory authority may request product samples as part of the initial registration process or during a variation application to ensure they are in compliance with local regulations. This checklist will provide you with a list of the essential regulatory information to consider in preparing artwork and samples for both registered and products to be registered, including templates for commitment letters if required samples are not yet available.
16. GMP Inspection Preparation Checklist
Good Manufacturing Practice (GMP) inspections are a routine component of the pharmaceutical production process to ensure that they are in compliance with such regulations. This checklist will provide you with an understanding of what to expect during a GMP inspection, including what may be required of you as a program manager, and how it may affect the registration timeline.
17. ISO-13485 Audit Preparation Checklist
An ISO-13485 audit of a manufacturer certifies that safety, quality, and regulatory requirements for a medical device and manufacturing facility are met. This checklist will provide you with an understanding of what to expect during an ISO-13485 audit, including what may be required of you as a program manager, and how it may affect the registration timeline.
18. Pharmacovigilance Planning Checklist
Pharmacovigilance is an important post-marketing activity to identify and evaluate safety information on a marketed medicine. A pharmacovigilance plan is typically required by the regulatory authority and submitted during the marketing authorization process. This checklist will provide you with key information to consider when preparing your own pharmacovigilance plan.
19. Quick Reference Glossary
Confused by all the jargon in regulatory affairs? This glossary is a one-stop-shop for definitions of frequently used terms that you may encounter in your regulatory work.
Acknowledgements
We’d like to thank the following partners for their technical expertise and support in the development of this toolkit:
– Tracey Brett, Supply Chain and RA Consultant
– Khushbu Khalil Katha, Regulatory and Compliance Manager, MSI Reproductive Choices
– Emily Morris, Senior Regulatory Affairs Manager, Medicines360
– Shams Ud-Dowla, Senior Deputy Manager, International Business Division, Renata Limited
– Md. Rasheful Goffar, Deputy Manager, Quality Assurance Division II, Renata Limited
This toolkit is made possible by the support of the American people through the United States Agency for International Development (USAID), which funded the Expanding Effective Contraceptive Options (EECO) project (Cooperative Agreement Number: AID-OAA-A-13-00088). The EECO project is led by Catalyst Global. The contents are the sole responsibility of the authors and do not necessarily reflect the views of USAID or the United States Government.
