How to use WHO dossier for Singapore vaccine registration ?

We’re back for our weekly deep dive into the fascinating world of regulatory affairs! This week, I want to tackle a topic that comes up surprisingly often in my conversations with clients, especially those looking to bring life-saving products like vaccines to new markets: How do you leverage a WHO Prequalified (PQ) dossier for registration in Singapore?

Many assume a WHO PQ means a straight shot, but as we as seasoned regulatory people know, it’s rarely that simple. While WHO Prequalification is an incredible achievement and a powerful foundation, there are always those crucial local nuances that need expert navigation.

What Exactly is a WHO Prequalified Dossier?

The World Health Organization (WHO) Prequalification program is a global initiative designed to ensure that key health products meet international standards of quality, safety, and efficacy. Think of it as a stamp of global assurance. WHO conducts a rigorous assessment, scrutinizing everything from the product’s quality data to the manufacturing site’s Good Manufacturing Practice (GMP) compliance. It’s a comprehensive review aimed at facilitating access to essential, quality-assured medical products, particularly for procurement by UN agencies and other international bodies.

What Kinds of Products Fall Under WHO PQ?

Initially, the program focused heavily on medicines for HIV/AIDS, TB, and malaria. Over time, it has expanded significantly. Today, WHO Prequalification covers a broad spectrum of products vital for global health, including:

Medicines (Finished Pharmaceutical Products and Active Pharmaceutical Ingredients): Especially generics and essential medicines.
Vaccines: This is a huge one! Ensuring vaccine quality and efficacy for global immunization programs is a cornerstone of WHO PQ.
In Vitro Diagnostics (IVDs): Products used for detecting diseases.
Immunization Devices: Like syringes and safety boxes.
Vector Control Products: Tools to fight vector-borne diseases.

Based on experiences and inquiries, vaccines are often the first product that comes to mind when leveraging WHO PQ. The principles, however, apply broadly across these categories.

Advantages of a WHO PQ Dossier

The advantages are:

A Global Seal of Quality: A WHO PQ product has already undergone a thorough evaluation by a globally respected authority. This immediately instills confidence in national regulatory agencies (NRAs) about the product’s quality, safety, and efficacy profile.
Streamlined Initial Review: For many NRAs, especially those with limited resources, a WHO PQ can significantly streamline their initial assessment, as much of the heavy lifting on the core scientific data has already been done.
Market Access and Procurement: For many manufacturers, WHO PQ is a prerequisite for supplying products to major international procurement bodies, opening up vast markets.
Robust Scientific and Quality Foundation: The WHO Prequalified dossier provides a comprehensive, pre-vetted scientific and quality package (often in CTD format). This means the core technical data, which is typically the most time-consuming to generate and compile, is largely established, significantly reducing the burden of its “major overhaul” when preparing for national submissions.

Bridging the Gap for Singapore Submission

Here are the key gaps we typically need to bridge:

Local Administrative & Legal Requirements (Module 1): The WHO PQ dossier, while often following the CTD structure, will have a WHO-specific Module 1. HSA, like any national authority, has its own unique Module 1 requirements. This includes specific application forms, declarations, appointment of a local company/agent (which, surprise, surprise, is a must!), and adherence to local legal frameworks.
Singapore-Specific Labelling & Package Inserts: Even if the core data is accepted, the product information (labels, package inserts, patient information leaflets) must be fully compliant with HSA’s detailed requirements for language, content, and format. This isn’t just a translation job; it’s a regulatory art form!
Good Manufacturing Practice (GMP) Conformity: While WHO conducts GMP inspections for PQ, HSA recognizes PIC/S GMP as the standard. Based on recognition agreements and internal evaluation, manufacturing sites can either be subjected to a GMP DEVA assessment or an overseas inspection.
Risk Management Plan (RMP): HSA requires a comprehensive Risk Management Plan, along with a Singapore-Specific Annex (SSA), to be submitted as part of the registration application for therapeutic products, including vaccines.
Vaccine-Specific Lot Release: This is a crucial point for vaccines! Even after registration, all imported registered vaccines require a notification to HSA on lot release information before they can be supplied in Singapore. This is a critical post-registration compliance step.
Dossier Format Alignment (ICH CTD/ACTD): While WHO PQ is increasingly aligned with CTD, HSA accepts both ICH CTD and ASEAN Common Technical Dossier (ACTD) formats. There can be subtle but important differences in how information is presented or what specific details are required within certain sections, especially if the ACTD format is chosen or if there are specific HSA guidance documents that refine the CTD expectations.

Essentially, a WHO PQ dossier gives you a solid scientific and quality foundation in which “a major overhaul” is essentially avoided when preparing for local submission.

How TRC Can Support Your Journey

TRC specializes in taking WHO Prequalified dossier and meticulously transforming it into a complete, compliant submission for HSA.

We don’t just translate documents; we understand the intent behind HSA’s guidelines and the specific nuances of what they’re looking for. From managing the intricate Module 1 administrative requirements, ensuring all labelling is compliant, to advising on GMP assessments and navigating the vaccine-specific lot release process – we cover all the bases.

Our “on-the-ground” practical experience in Singapore regulatory affairs means we can foresee potential roadblocks and proactively address them, streamlining your path to market. We work like an extension of your own team, guiding you through every step, ensuring that your life-saving vaccines, or any other WHO Prequalified product, reach the patients who need them, right here in Singapore.

Ready to make your WHO PQ a launchpad for Singapore market access? Let’s talk!

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