Why Reference Agency Approval Isn’t Enough for Local Registration

We often get leads from prospects telling us:

“My product is FDA/EMA approved, so there shouldn’t be any issue for local submission. Efforts on your end should be minimal – can we reduce costs?”

I’m sure those who know the reality are quietly laughing behind their screens as I say this.

Why Do We Still Need Local Preparation?

When preparing a regulatory submission, having reference agency approval:

Supports your application, as the dossier has been reviewed by a stringent authority
Provides assessment reports that local health authorities can leverage to evaluate safety, quality, and efficacy

But here is the reality: reference agency dossiers are not fully representative of local requirements. Regulations are built upon international standards and incorporate specific national requirements, dossier formats, and administrative expectations that local marketing authorization holders should adhere to.

Critical Gaps We Often See

Generics: Local bioequivalence (BE) requirements, acceptance of foreign BE studies, and strict reference product criteria can differ greatly from those in the US or EU.
Biosimilars: Local authorities may request additional analytical data or bridging studies when the reference biologic is sourced differently.
NCEs: While clinical data may be robust globally, gaps can occur if local clinical pharmacology factors—such as food effects, drug interactions, or special population data—are insufficient or missing.
Stability studies not performed in accordance with Zone IVb requirements.
Process validation performed but lacking validation data for all commercial-scale batches (only pilot scale provided), absence of hold time validation data for in-process materials or bulk product, or no justification for process parameter ranges or their linkage to critical quality attributes (CQAs).
Manufacturing controls not clearly demonstrating the linkage between drug substance and finished product manufacturer.
GMP standards adopted not aligned with PIC/S requirements.

Other Common Issues We Encounter

Dossiers submitted not in the required ASEAN CTD or ICH CTD format
Outdated Quality Overall Summary (QOS) that does not reflect current drug substance (DS) and drug product (DP) changes
“‘Grandfather” products registered based on old regulations or legacy processes may still be accepted in reference countries but often fail to meet evolving local regulatory requirements leading to challenges in registration.

What Should You Do?

If you want to register your product locally, it is essential to:

Conduct regulatory intelligence to understand local requirements and assess your dossier gaps before submission.
Engage an external local expert to perform a targeted gap analysis to de-risk your registration process.

How TRC Can Support You

We can help by:

Identifying missing documents or data
Adapting dossiers efficiently to local requirements

If you need a local regulatory expert or another pair of eyes to help you, we are just a click away!

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