In July 2025, the Drug Regulatory Authority of Pakistan (DRAP) published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally manufactured biological medicines. This follows news that in June 2025, the Hong Kong Department of Health released a timetable for launching its Centre for Medical Products Regulation (CMPR) and is now starting to independently approve medical products.
Pakistan’s biological product guidance
n Pakistan, DRAP noted that the guidance document was created to provide a better illustration of data requirements for clinical trials of locally manufactured biological drugs. The guidance applies to companies that intend to seek marketing authorization for biologicals.
For the most part, the guidance applies to products that use ‘imported bulk/concentrate/ready-to-fill/naked vials’. Here, companies requesting approval of these products must provide complete clinical trial or provide biosimilarity data ‘as submitted for approval either from regulatory body of country of origin or by any reference regulatory authority as adopted by Registration Board’. Additionally, applicants must include the submission of both a good manufacturing practice (GMP) certificate for the company producing the vials, and free sale and lot release certificates from their country of origin.
DRAP outlines requirements for companies to perform accelerated and real-time stability studies for the biological drug substance and analytical studies to evaluate the protein and particle content; and assess in vitro biological activity. These tests should all be carried out locally, within Pakistan.
When it comes to locally manufactured vials, DRAP outlines the requirement for applicants to submit complete clinical trial or biosimilarity data, which is dependent on the biological product type the application is being made for.
Hong Kong’s Centre for Medical Products Regulation (CMPR)
In 2023, Hong Kong’s government announced a long-term goal of establishing a regulatory agency to authorize drugs and medical devices without relying on approvals from other drug regulatory agencies.
In their roadmap, Hong Kong authorities aim to create the CMPR by the end of 2026. Then, ‘primary evaluation’, of applications will follow with full implementation of primary evaluation being complete by 2030.
To get to this point, legislation must be enacted to enable CMPR to regulate Western and Chinese medicines and establish a statutory framework for regulating medical devices. So far, Hong Kong has implemented the ‘1+’ mechanism, which allows companies with local clinical data and prior approval by at least one global reference regulatory agency to seek approval. In 2024, this program was extended to cover all new drugs. It has also been outlined that the initial phases of the regulatory implementation will cover new indications, strengths, and dosage forms for both chemical and biological products that are already registered in Hong Kong.
Additionally, Hong Kong’s health department has already issued good practice guides, improved the electronic registration platform, introduced new registration pathways, and developed fee-charging mode to prepare for primary evaluation. They will also be publishing and utilizing a Chinese Medicine Development Blueprint to optimize the regulation of traditional products.
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