Asia-Pacific Roundup: China’s NMPA strengthens supervision and responsibilities of contract manufacturers

The National Medical Products Administration (NMPA) has published rules strengthening the supervision and administration of contract manufacturers in China.

NMPA’s goals for the document include ensuring marketing authorization holders (MAHs) and contract manufacturers jointly ensure drug quality and safety, and clarifying the obligations and responsibilities of all parties. A translation of the Chinese document published last week is divided into two main sections, one on contract manufacturers’ responsibilities and another about supervising outsourced production.

Contract manufacturers should establish a mechanism for evaluating MAHs and their products. Using the mechanism, NMPA expects manufacturers to assess the MAH’s qualifications, quality management capabilities, the risk factors of the proposed products, and the feasibility of accepting technical transfer and of co-line production. MAHs should cooperate actively and truthfully with the evaluation team.

Companies can only sign deals after the MAH passes an evaluation. NMPA wants contract manufacturers to prioritize cooperation with MAHs “that possess independent research and development management capabilities and master of key process technologies of the contracted products.”

MAHs and contract manufacturers should strengthen risk identification, communication, and analysis when transferring products for outsourcing. If elements such as software, hardware, and quality management make tech transfer difficult or drug quality risks arise, partners should communicate and act immediately. NMPA expects companies to end projects when risks are difficult to control effectively.

The document lists tasks that contract manufacturers should perform during tech transfer, and outlines the need for ongoing MAH cooperation on quality management. The tasks cover activities including the validation of facilities and equipment, the analysis of tech transfer data, and the formulation of technical documents.

For high-risk products such as sterile drugs, NMPA expects MAHs to supervise validation activities during on-site inspections at least once a year. Supervision should cover sterilization process validation and aseptic process simulation tests. Either the MAH or the contract manufacturer should have at least three years of commercial experience manufacturing sterile drugs of the same dosage form.

MAHs that outsource production of a drug to multiple companies must ensure all their partners follow the approved manufacturing process. When there are differences in conditions, contract manufacturers should cooperate with MAHs to conduct comparative analysis, carry out risk assessments on the differences, and formulate risk prevention and control measures. MAHs must compare quality regularly.

NMPA has asked provincial drug regulatory authorities to urge MAHs and contract manufacturers to conduct comprehensive self-inspections in line with the new requirements. If a situation is inconsistent with the requirements, the MAH and contract manufacturer should rectify the issues within one year. Companies should clearly state the reasons for fixes that take longer than one year to adopt.

NMPA Notice

Australia’s TGA raises concerns about increasing trade in unapproved peptide products

The Therapeutic Goods Administration (TGA) has voiced concerns about increases in imports, supply, compounding, and advertising of unapproved peptide products in Australia.

TGA said it is aware “that the use or supply of unapproved peptide products is being promoted on a number of online and social media platforms.” The ads claim a range of health benefits including weight loss, muscle growth, anti‑aging, and enhanced cognitive and athletic performance.

None of the promoted products have been evaluated for safety, quality, or effectiveness by TGA. The agency said the practices raise significant regulatory and public health risks, leading it to monitor the safety and legal implications of the activities.

TGA named BPC‑157, GHK‑Cu, TB‑500, retatrutide, and CJC‑1295 as examples of unapproved peptides. BPC‑157, GHK‑Cu, and TB‑500 are among the peptides that the US Food and Drug Administration (FDA) is considering allowing licensed facilities to compound. The FDA will meet in July to discuss its position on seven peptides, including molecules it deemed unsafe in a Biden-era ruling.

Retatrutide is an agonist of GIP, GLP-1, and glucagon receptors that Eli Lilly is developing. Lilly posted Phase 3 data on the triple agonist in December but has yet to win approval.  The FDA has sent warning letters to companies accused of providing the unapproved peptide for human use.

TGA Notice

India addresses the EU, quality management systems in updated Medical Devices Rules

The Indian government has updated the Medical Devices Rules, 2017 with information on quality management systems and using European Union authorizations.

Officials have added information on quality management systems to a section of the rules about Class A non-sterile and non-measuring medical devices. The updated rules require manufacturers and importers of the devices to self-certify compliance with the standards and quality management systems specified in the document. Previously, the section only mandated self-certification with standards.

The EU update affects a section on the permission to import or manufacture a medical device that does not have a predicate device. Previously, the law said a clinical investigation may not be needed when the device is approved in Australia, Canada, Japan, the UK, or the US. The update adds the EU to the list of reference regions. Other sections of the law already included the EU as a reference region.

In a separate update, officials required manufacturers to include the license number of any third-party sterilization site on the device’s label. The update also added prices for testing products including syringes and surgical dressings.

Draft Rules, More

TGA clarifies therapeutic goods are unaffected by chemical production and import ban

TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical devices, and biologicals.

Responding to stakeholder queries, TGA said therapeutic goods are not affected by prohibitions imposed under the Industrial Chemicals Environmental Management Standard (IChEMS). The framework prohibits the import, manufacture, and use of specified chemicals in Australia. Certain PFAS chemicals, UV-328, and Dechlorane Plus are among the chemicals covered by IChEMS.

TGA said IChEMS does not apply to chemicals used for therapeutic purposes. That limitation of the standard’s scope extends to the primary and secondary packaging of medicines and biologicals, as well as to the primary packaging, instructions for use, and spare parts of medical devices.

The agency posted two statements about the exemption of medical devices from the PFAS ban last year. While TGA’s second statement clarified that medicines and biologicals are exempt from the ban, neither notice addressed chemicals other than PFAS.

TGA Notice

Malaysia’s NPRA updates drug registration guidance, harmonizes blister pack labeling

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its guidance about product registration holders (PRHs) and blister packaging.

The updated product registration guidance prohibits PRHs and manufacturers from having names that reflect pharmaceutical quality, diseases, or organs. NPRA cited “Amalan Perkilangan Baik,” the Malay for good manufacturing practice, as an example of a name prohibited under the updated rules.

The update also permits government agencies and research or higher education institutions to establish subsidiary companies through their private wings to serve as PRHs and manufacturers. NPRA has blocked private companies from using names or acronyms that resemble those of agencies or institutions to avoid confusing consumers.

NPRA posted the update alongside a circular about the harmonization of the blister packaging labeling requirements for natural products, pharmaceuticals, and health supplements.  

NPRA Notice, More 

Other News:

NMPA held a training program on the inspection, rectification, and quality improvement of vaccines and blood products. The program was intended to reinforce oversight of the quality and safety of the products in China. NMPA Notice