Hong Kong’s Department of Health (DH) has begun a phased transition to the independent assessment of primary data on new drugs submitted for approval in the city.
In recent years, Hong Kong has started laying the groundwork for “primary evaluation.” The term refers to a new and comprehensive regulatory process to approve applications for registration of new drugs. In the evaluations, officials will independently assess primary data from preclinical trials, clinical studies, pharmacovigilance, manufacturing, and quality control before and after drugs come to market.
The initial implementation of primary evaluation covers extended applications, such as new indications, strengths, posology, and dosage forms. DH has written to pharmaceutical associations and stakeholders, including holders and applicants of certificates of drug registration, to tell them it is accepting extended applications for primary evaluation.
Hong Kong is transitioning to primary evaluation to accelerate access to new drugs. Once the approval mechanism is in place, companies will be able to launch medicines in Hong Kong without relying on and waiting for authorization from non-local regulatory authorities. Officials expect medical R&D, testing, and related industries in Hong Kong to benefit from the change.
The move to the new pathway is built on experience of the “1+” drug approval mechanism, which the government implemented in 2023. Through the mechanism, companies with new drugs supported by local clinical data and recognized by local experts can seek authorization in Hong Kong after receiving approval from one overseas reference agency. Previously, companies needed two overseas approvals.
Officials initially restricted the 1+ mechanism to treatments for life-threatening or severely debilitating diseases. Hong Kong extended the pathway to cover all new drugs, including chemical and biological entities, new indications, vaccines, and advanced therapy products, in 2024. Officials have approved 19 products under the mechanism.
The start of primary evaluations is one of two key 2026 milestones in the development of Hong Kong’s regulatory capabilities. The other key milestone is launching the Hong Kong Centre for Medical Products Regulation, an agency that will register drugs and medical devices under the primary evaluation model.
Singapore’s HSA starts accepting eCTD packages for regulatory dossier applications
The Health Sciences Authority (HSA) has begun accepting regulatory dossier submissions for approval in Singapore in the electronic common technical document (eCTD) format.
HSA launched an eCTD portal and began accepting test filings in September. After giving companies six months to trial the system with dummy application numbers, the agency started accepting actual filings through the portal in the eCTD format on 1 April. HSA has established SG-HSA eCTD version 1.1 as the official standard for all submissions.
The agency has provided technical files for defined lists, document matrix, and submission type matrix for real-time access and validation. To help users navigate the portal, HSA has created a training presentation, Q&A document, and manual. The agency has also updated guidance documents to state that eCTD submissions are possible.
Companies may continue making their current non-eCTD submissions. However, HSA is strongly encouraging applicants to switch to the eCTD format. The agency will provide advance notice before any subsequent phases of the rollout.
HSA shared details of the launch of the portal alongside news of changes to chemistry, manufacturing, and controls (CMC) dossiers. From 1 June, applicants will need to provide an official letter declaring that there are no known quality defects that would require amendment or updates to the submitted CMC package.
The requirement, which HSA said promotes good submission practices, is intended to minimize the inadvertent submission of superseded technical data and improve regulatory efficiency. HSA updated its guidance on registering therapeutic products in Singapore to reflect the requirement.
India’s DCC backs development of real-time portal for tracking drug supply chain
India’s Drugs Consultative Committee (DCC) has approved plans to develop a centralized, real-time digital portal for tracking pharmaceutical products.
At a recent meeting, DCC heard the case for having an end-to-end mechanism for tracking medicine production, imports, exports, sales, distribution, and stock. The proposed portal would cover products regulated under the Narcotic Drugs and Psychotropic Substances Act, 1985.
DCC discussed the scope and key functional features of the portal, regulatory and legal considerations, role of the Central Drugs Standard Control Organization (CDSCO) and state drug regulatory authorities, the implementation strategy, and the anticipated benefits of the system. The discussion informed DCC’s decision to approve the proposal.
The committee recommended CDSCO meet with the Central Bureau of Narcotics (CBN) to discuss the planned portal. DCC’s recommendation reflects CBN’s maintenance of a portal for manufacturing units. The committee suggested making the new portal available to “all the concerned agencies” to support surveillance and monitoring.
Japan’s PMDA shares guidance on pre-specifying manufacturing change categories
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has posted advice about pre-designating change categories for manufacturing process parameters.
Applying the International Council for Harmonisation’s Q12 guidance, PMDA requires drugmakers to describe process parameters that are Established Conditions in the manufacturing method sections of their marketing applications. Companies must pre-designate the parameters as requiring either a partial change approval application or a minor change notification to support post-approval revisions.
PMDA’s early consideration document outlines factors affecting pre-specification of change categories. The categorization depends on the potential risk to product quality when the parameter is changed. PMDA wants companies to evaluate the risk by considering the range of normal procedures specified in product standard specifications.
Minor change notifications are reserved for updates within the proven acceptable range and non-critical process parameters. Partial change approval applications are needed when critical process parameters are at or near the edge of the acceptable range.
PMDA expects companies to have objective evidence showing scientific validity to support requests for minor change designations. The agency warned against relying solely on qualitative statements such as “sufficiently controllable by the equipment used.” Companies that establish wide acceptable and normal operating ranges are best positioned to avoid the post-approval burden of partial change approval filings.
China’s NMPA suspends review of semaglutide copy over data protection issues
Hangzhou Jiuyuan Genetic Biopharmaceutical has reported the suspension of the regulatory review of its biosimilar copy of Novo Nordisk’s GLP-1 receptor agonist semaglutide.
Jiuyuan Gene reported in February that China’s National Medical Products Administration (NMPA) had accepted a filing for approval of the candidate. The biotech, which plans to sell the drug as Jikeqin, filed for NMPA approval after showing the biosimilar is clinically equivalent to semaglutide in a Phase 3 trial in people with obesity.
However, Jiuyuan Gene revealed in its annual report that the review and approval of the biosimilar is suspended. The biotech said the suspension is in place because the product “is subject to data protection provisions under agreements with governments of other countries.”
Novo successfully defended its semaglutide patent in China last year, overturning an earlier ruling that it was invalid. However, the patent expired in China on 20 March, clearing one barrier to copies of the drug.
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