Asia-Pacific Roundup: China overhauls drug administration law with a focus on incentivizing innovation

China has updated the implementation of its Drug Administration Law, setting out plans to revise its drug research and registration system and make other changes to support innovation.

The regulations passed into law at the end of 2025 and China’s State Council released the full text of the changes last week. Publication of the full text revealed the extent of the changes, which affect most parts of the existing law. The changes are intended to promote drug innovation, strengthen management of online sales of medicines, and reinforce drug safety supervision.

When the revisions take effect on 15 May, the law will set out the powers that China’s National Medical Products Administration (NMPA) must adopt regulatory procedures for breakthrough drugs, conditional approvals, priority reviews, and other mechanisms for accelerating drug launches.

The legislation mandates marketing exclusivity periods for certain types of medicines. Developers of new chemical entities will have up to six years of data protection from the time a product is registered. China will offer up to two years of market exclusivity for pediatric medicines and up to seven years of market exclusivity for rare disease therapies.

Other sections of the law refine the responsibilities of marketing authorization holders (MAHs), which will need to establish and improve systems for drug quality assurance and pharmacovigilance. The law establishes rules about assessing the effect of manufacturing changes on drug quality and performing post-market evaluations of approved products.

China has tightened the rules on drug production, including by tasking MAHs with overseeing contract manufacturers and verifying suppliers. Medicines made overseas must comply with the relevant Chinese laws and regulations.

NMPA and other Chinese organizations are aiding the implementation of the law, both by educating the industry about the changes and by improving supporting systems. Publicity, interpretation, and training are planned to help companies adapt to the specialized and technical regulations.

NMPA Notice, Implementing Regulations (Chinese)

New Zealand’s Medsafe starts reviewing vision loss risk on GLP-1 receptor agonists

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is reviewing the risk of acute persistent visual loss in people taking GLP-1 receptor agonists.

Last year, the European Medicines Agency’s safety committee found that the eye condition non-arteritic anterior ischemic optic neuropathy (NAION) is a very rare side effect of semaglutide, a GLP-1 receptor agonist that Novo Nordisk markets for diabetes and obesity as Ozempic, Rybelsus, and Wegovy. The agency recommended that NAION was listed as a very rare side effect on the semaglutide label.

Currently, New Zealand data sheets for semaglutide and other GLP-1 receptor agonists do not list NAION or other forms of persistent visual loss as adverse effects. The New Zealand Pharmacovigilance Database had received two reports of patients taking GLP-1 receptor agonists who developed sudden vision loss as of 1 December. Both reports involved patients taking semaglutide.

To gather more data, Medsafe has added the safety concern to its medicine monitoring scheme. The agency is encouraging people to report sudden vision loss in one or both eyes in patients taking GLP-1 receptor agonists. Medsafe’s monitoring period will close on 26 July.

The request applies to all GLP-1 products approved in New Zealand. Besides semaglutide, Novo sells another GLP-1 drug, liraglutide, as Saxenda and Victoza in the country. Eli Lilly has New Zealand approvals for Mounjaro and Trulicity, products that respectively contain the GLP-1 receptor agonists tirzepatide and dulaglutide.

Medsafe Notice

Singapore’s HSA updates guidance on cell, tissue, and gene therapy defects and recalls

The Health Sciences Authority (HSA) has updated its procedures for reporting defects and recalls of cell, tissue, and gene therapy products in Singapore.

HSA updated the document as part of its push to make regulations clearer and more efficient. Changes include clarifications on reportable and non-reportable defects, updated guidance on the investigation and risk assessment of defects, revised guidance on the notification of recall actions to stakeholders, and a new product defect reporting form for clinical trial products.

In a new section, HSA said companies must report defects in batches that have been, or are intended to be, imported or supplied in Singapore. Companies must also report manufacturing deviations or good manufacturing practice noncompliance at any manufacturing site for products registered or supplied in Singapore, even if the affected batches have not been imported or supplied in the country.

“Such issues may indicate systemic problems that could affect all batches from the manufacturing site,” HSA said. “Reporting these enables HSA to review the risk mitigation measures, and ensure the systemic issues are resolved to maintain product quality and patient safety.”

HSA has updated the recall section of the document with information about the need to send written communications to provide documented records of recall instructions. Written communications should be addressed to specific contact persons to prevent misdirection, HSA said. Companies must give HSA an electronic spreadsheet of all affected customers.

HSA Notice

Indian medtech companies’ adverse event under-reporting spurs regulatory pressure

The Indian Pharmacopoeia Commission (IPC) has written to domestic medical device manufacturers to raise concerns about their under-reporting of adverse events.

IPC has overseen the Materiovigilance Programme of India (MvPI), which was established in 2015, since 2018. As the MvPI national coordination center, IPC has worked to make it easier for device companies to report adverse events, including by launching the adverse drug reactions monitoring system (ADRMS) in 2024. ADRMS is a national digital platform for reporting drug, device, and vaccine adverse events.

Despite efforts to simplify reporting, IPC said under-reporting by domestic medical device manufacturers continues to be a concern. Under-reporting limits the completeness of national safety data and delays the detection of potential risks in the Indian market, IPC said.

The situation led IPC to ask marketing authorization holders to ensure strict compliance with the rules, “in letter and spirit.” IPC wants device companies to promptly report all medical device adverse events, regardless of whether they are serious or non-serious and known or unexpected. Preferably, companies should use ADRMS to file reports.

IPC Notice, More

MDA updates requirements for medtech companies participating in Malaysian tenders

Malaysia’s Medical Device Authority (MDA) has changed its rules on the procurement of medical devices by healthcare institutions.

Under a policy that took effect on 28 January, any company or supplier representative participating and succeeding in tender procurement activities is classified as an establishment. Supplying devices through a tender meets the definition of placing a product on the market. Those positions affect the rules for companies that supply products through tenders.

Companies must have a valid establishment license to conduct distribution activities and implement a quality management system based on Good Distribution Practice for Medical Devices. The supplier takes on all post-market responsibilities, including the need to report incidents to MDA, investigate complaints, and implement field corrective actions and product recalls as needed.

Healthcare facilities sourcing devices via tenders must obtain certain documents from suppliers before finalizing procurement agreements. Companies must provide copies of their medical device distributor establishment licenses and valid medical device registration certificates for the relevant products. A letter from the authorized representative or the original establishment is also required.

MDA Notice

Other News:

Australia’s Therapeutic Goods Administration (TGA) has said it continues to see imports of counterfeit Botox vials despite issuing a warning about the products in July. TGA Notice

Asia-Pacific Roundup: China overhauls drug administration law with a focus on incentivizing innovation

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