Asia-Pacific Roundup: China and Malaysia start reciprocal medical device reliance pilot program

Regulatory agencies in China and Malaysia have started a pilot program that will grant companies based in each country access to accelerated paths to market for medical devices.

The reciprocal agreement has two components. China-based manufacturers of certain medical devices can use Malaysia's verification pathway, and Malaysia-based manufacturers of certain medical devices can use China’s green channel. A pilot assessment of the regulatory reliance program started on 30 July and will run through 30 September.

China’s National Medical Products Administration (NMPA) created the green channel to reduce review times for certain medical devices covered by Chinese patents to 60 working days. A paper supported by the trade group MedTech Europe warned in 2023 that the pathway “does little for foreign firms that conduct R&D outside of China and may even disadvantage them.”

Malaysia’s verification pathway reduces the review times for certain devices to 30 working days. The Medical Device Authority (MDA) set up the pathway to accelerate access to devices with clearances and approvals in overseas territories including the European Union, Japan and the United States.

After signing a memorandum of understanding in 2023, MDA and NMPA agreed to mutually recognize regulatory decisions for in vitro diagnostic medical devices under a reliance pathway. MDA marked the start of the two-month pilot assessment of the reliance program by publishing the criteria for taking part in the scheme.

To access Malaysia’s verification pathway, a company must be based in China and own and operate their own facility in China. MDA has excluded third-party brand owners such as rebranders, relabelers and assemblers. NMPA has imposed the corresponding restrictions on access to its green pathway, limiting participation to Malaysia-based companies that own and operate their own facilities in Malaysia.

MDA will accept filings for Class II devices that are approved by a provincial Chinese medical products administration or Class III devices that are approved by NMPA. China’s pathway is open to Class B, C or D devices approved by MDA. Malaysia will give priority to filings involving rare diseases and innovative devices. NMPA has not stated its priorities. Both agencies will accept up to six applications for the pilot.

MDA Notice

WHO designates Japan’s PMDA as listed authority

The World Health Organization (WHO) has designated Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a Listed Authority.

Officials created the WHO-Listed Authority (WLA) framework in 2022 to replace the stringent regulatory authority (SRA) system and support regulatory reliance. The SRA system, which WHO defined in 2008, was based on International Council of Harmonization membership. WHO designed the WLA framework to be more transparent and evidence-based than the old system.

PMDA was recognized as an SRA but was not part of the first sets of WLA designations, in which WHO named agencies in countries including Singapore and South Korea as Listed Authorities. Japan was part of a recent batch of new WLAs that included regulatory agencies in Canada and the United Kingdom.

WHO said the designation of the agencies under the WLA framework was “an important step in moving beyond the old SRA system, while ensuring continuity and stability in global procurement processes of quality-assured medical products.” The WLA framework allows the WHO prequalification program to rely on the decisions of designated agencies.

Officials disclosed the new WLA designations alongside the expansion of the listing for Korea’s Ministry of Food and Drug Safety. The agency completed the WLA assessment for medicines and vaccines in 2023. WHO recently expanded the scope of the agency’s listing to cover all regulatory functions.

Press Release

India’s CDSCO creates new registration process for dual use no objection certificates

India’s Central Drugs Standard Control Organization (CDSCO) has established a new process for applying to import products that have medical and non-medical uses.

The process applies to drugs imported in bulk for non-medicinal use. Companies can now apply for a dual use no objection certificate (NOC) that covers the bulk import using India’s online Sugam portal. The pathway is intended to simplify the process of obtaining a dual use NOC. CDSCO said it will issue NOCs that last one year, “subject to prescribed conditions for such drugs,” to cut compliance burdens.

Registration under the new process began last week. Starting on 1 September, CDSCO said that only users that it has registered and approved “as dual use NOC traders/actual manufacturers will be allowed to apply for dual use NOC on the new Sugam portal.”

CDSCO has published a list of the documents that companies will need to register for dual use NOCs and shared guidance on the application process. Companies need to provide specific details of how they plan to use the imported product, including information such as a brief manufacturing process or flowchart if they are converting the substance to another drug.

CDSCO Notice

DRAP grants exemption to imports of unregistered drugs used in Pakistan’s hospitals

The Drug Regulatory Authority of Pakistan (DRAP) has exempted some oncology, cardiac and “essential lifesaving” drugs from registration requirements.

Pakistan’s Drugs Act, 1976 prohibits companies from exporting, importing or manufacturing unregistered drugs. However, the legislation also empowers the government to exempt any drug or drug class from the requirements if the change is in the public interest.

DRAP has used the power to allow the importation of certain drugs for use in hospitals and institutions, which cannot sell or distribute the product or use it in a clinical trial. Importers need to obtain a clearance certificate before customs clearance and maintain a record of the use of the product.

The exemption applies to “anticancer drugs, cardiac drugs and any essential lifesaving drugs so considered by the licensing authority.” The drug must be on free sale in the country of origin, unless they are “life saving vaccines and anti-sera for human use only, where pre-qualification by WHO or approval of any regulatory authorities as defined by the Registration Board is provided,” DRAP said.

DRAP Notice

TGA launches consultation to address concerns about unapproved medicinal cannabis

Australia’s Therapeutic Goods Administration (TGA) has started a public consultation into the safety and regulatory oversight of unapproved medicinal cannabis products.

Last week, TGA gave notice of its intent to launch a consultation in response to “increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products.” TGA began the consultation on Monday and is accepting feedback until 7 October.

The agency is seeking feedback on potential changes including the transfer of regulatory and legal responsibilities from the prescriber to the product sponsor. Other changes under consideration include developing a framework to incentivize sponsors to gather evidence to support safety and efficacy and making additional scheduling amendments to address safety concerns.

TGA plans to develop regulatory options using the consultation feedback. As well as seeking feedback on potential regulatory changes, the agency is asking for views on the current quality and safety requirements, emerging safety concerns and issues specific to certain dosage forms.

TGA Notice, Consultation

Other News:

India’s CDSCO has warned manufacturers that it will not extend the revised deadline for changes to the good manufacturing practice certificate application process. The agency pushed back the deadline by one month in July. Last week, CDSCO said there will be no extension beyond the revised 15 August deadline. CDSCO Notice

Asia-Pacific Roundup: China and Malaysia start reciprocal medical device reliance pilot program

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