Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in China

The National Medical Products Administration (NMPA) will allow the import and sale of pre-approval commercial-scale batches of overseas-marketed drugs that have authorization certificates in China.

NMPA said the policy is intended to cut the time between drug approval and market supply in China and support the early use of innovative and urgently needed drugs. The policy applies to several categories of overseas-marketed products. Batches of the medicines must meet certain requirements to be eligible for importation and sale in China.

The agency said the new policy “exempts the submission of the document permitting the drug to be marketed from the overseas drug regulatory authority when applying for import filing for pre-approval commercial-scale batches of innovative and modified new drugs produced overseas.”

NMPA will accept overseas batches of originator or modified drugs, treatments for conditions on the list of rare diseases, and products that are approved under the accelerated registration scheme. The importation offer is also open to drugs on lists of priority products such as the National List of Drugs in Shortage and products that were temporarily imported via a pathway for urgently needed medicines before receiving approval in China. The drug regulatory department can also allow other medicines.

Companies seeking to bring eligible products into China must comply with the general provisions for drug importation and with requirements specific to the program. The drug must be approved by an overseas drug regulator. The manufacturer must have received approval or sent notification of any post-marketing changes through interactions with the authority.

Quality standards must comply with those enforced in China. The production site and manufacturing process should be consistent with information specified in China’s approval documents or the content filed as required. Either Chinese or local regional authorities must have performed a good manufacturing inspection of the facility. Instructions and labels must be consistent with the Chinese documents.

Marketing authorization holders (MAHs) that want to benefit from the import policy should submit an application letter with their designated domestic responsible person. Port drug regulatory departments responsible for accepting the import filing applications will carry out the relevant inspection work. MAHs and responsible persons should strengthen risk management of pre-approval commercial-scale batches, NMPA said.

NMPA Notice, More

Japan’s PMDA shares thoughts on ensuring the quality of fecal microbiota transplants

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published advice for developers of fecal microbiota transplantation (FMT) treatments.

FMT entails transplanting enteric bacteria prepared from the feces of healthy human donors. PMDA said the term does not apply to transplants of specifically identified bacterial strains. Researchers have identified FMT as a way to restore a balanced gut microbiome to treat conditions such as recurring Clostridioides difficile infections. Australian and US regulators have approved FMT products.

To support development in Japan, PMDA has presented its current regulatory perspective on the quality of FMT products at the initial development stage. The document leverages PMDA’s own experience and international regulatory guidelines and literature. PMDA’s advice covers donor eligibility and quality control.

“Because FMT products are comprised of enteric bacteria directly derived from donors without substantial processing and intended to be transplanted into patients, eligibility of human donors of feces must be assessed from a multi-angled view of safety,” PMDA said. “Interviews and tests should be appropriately used in combination to determine whether prospective donors are fully qualified.”

The agency said physicians should interview prospective donors about their health history and lifestyle. Donors and their feces should be tested for infections with pathogenic bacteria, fungi, and viruses using highly sensitive detection methods.

PMDA has provided a list of target pathogens but said the scope of the screening should reflect the donor’s location, the target disease, and the risk-benefit profile of the FMT product. Emerging pathogens beyond those listed by PMDA may need to be tested. Developers that omit any of the listed pathogens should justify the decision. Blood samples should be tested for at least hepatitis B and C and HIV.

In the quality control section, PMDA explains that the composition of the gut microbiota varies between individuals and between samples taken from the same donor. The variability led PMDA to recommend that developers collect data on the microbiota composition throughout development to ensure safety and efficacy.

PMDA wants developers to investigate which bacterial strains and microbiota are effective in the target disease through methods such as gene analysis results and clinical trial data. The agency said it is important to ensure that the effective characteristics are consistently maintained within a certain range across lots of FMT products.

PMDA Notice

Malaysia’s MDA seeks feedback on medical device change management and definitions

Malaysia’s Medical Device Authority (MDA) has shared draft guidance on medical device change management and definitions.

The change management draft will replace an existing change notification document. MDA plans to enforce the new version concurrently with the launch of MeDC@St 3.0, an upgraded version of the agency’s web portal that is in development. The agency said in a timeline published last year that the system would be ready in 2027.

MDA’s change management draft outlines a risk-based approach. The document covers change management general principles, categorization, reporting, and alternative pathways. MDA is accepting feedback on the draft until 16 December.

The agency also published draft guidance on medical device definitions. The draft document defines accessories, components, and spare parts of medical devices. MDA has shared examples to clarify the definitions. The comment window for the draft closes on 18 December.

MDA Notice, More

NMPA posts guidelines on quality management inspections for online medtech supply

NMPA has published guidelines about on-site quality management inspections for organizations involved in the online sale of medical devices in China.

The agency created the guidelines to standardize on-site inspections. NMPA said the guidelines apply to inspections of medical device online sales operators and medical device e-commerce platform operators.

“Considering that medical device online sales operators and e-commerce platform operators may differ in their business models, service methods, and scope of operations, during the inspection, operators may, based on their business models and characteristics, identify reasonable omissions in comparison with the guidelines and give the reasons in writing for these omissions,” NMPA said.

Inspectors will pass sites that meet all the applicable requirements or can correct any problems during the assessment. Depending on the number and severity of issues, sites that cannot fix problems during the inspection will either be graded as “rectification within a specified period” or “failed.”

NMPA Guidelines

Other News:

Malaysia’s MDA has delayed enforcement of new procedures for medical device imports. The agency will now enforce the procedures from 1 July 2027, compared to 2 January 2026 under the prior timeline. Stakeholders can voluntarily submit Verification Slip applications for nonmedical devices that fall under medical device tariff codes via the online permit system from 1 June 2026. MDA Notice

The National Pharmaceutical Regulatory Agency (NPRA) has answered frequently asked questions (FAQs) about reporting serious breaches of good clinical practices in Malaysia. The document explains how to determine if a breach is serious, the regulatory requirement for reporting breaches, and what actions NPRA may take when it receives a report. NPRA FAQ

Asia-Pacific Roundup: NMPA adopts policy to cut time between drug approval and market supply in China

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