To support the export trade of medical devices and standardize the handling of service-related matters by drug regulatory authorities in issuing certificates for the export sales of medical devices, the National Medical Products Administration (NMPA) has revised and released the "Regulations on the Administration of Certificates for Medical Device Export Sales." These regulations will take effect on May 1, 2026. The former "Announcement on the Issuance of Regulations for the Administration of Certificates for Medical Device Export Sales" (No. 18 [2015]) by the China Food and Drug Administration (CFDA) will be simultaneously repealed.

The "Regulation" is an important measure by the National Medical Products Administration (NMPA) to implement the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision and Promoting High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53). It strongly supports the export of medical devices and optimizes the handling of service-related matters for issuing export sales certificates for medical devices by drug regulatory authorities.

The Regulations specify that applicants who intend to export medical devices registered or filed in China shall apply to the provincial drug regulatory department at their location for the issuance of the "Medical Device Export Sales Certificate (I)" to certify that the product has been approved for production and sale within China. Applicants intending to export medical devices not registered or filed in China shall apply to the provincial drug regulatory department at their location for the issuance of the "Medical Device Export Sales Certificate (II)," certifying that the product is managed as a medical device within China but has not been registered or filed within China, and that the manufacturing enterprise meets the production conditions required by the medical device production quality management standards.

The Regulations also specify that the validity period of the Medical Device Export Sales Certificate should not exceed the earliest expiration date of all the certificates submitted by the enterprise in the application materials. The validity period of the export sales certificate for Class I medical devices shall not exceed 3 years.

The issuance of the Regulation will provide broader support and more convenient services for the export of China's medical device products, help accelerate the "going global" of China’s medical device products, better reach the world, and contribute to global public health.

On December 22, the National Medical Products Administration (NMPA) Announcement No. 120 of 2025 on the Revision of Montelukast Formulations Instructions: Based on the assessment results of adverse drug reactions, and to further ensure public medication safety, the NMPA has decided to uniformly revise the instructions for Montelukast formulations (including Montelukast Sodium Tablets, Montelukast Sodium Chewable Tablets, Montelukast Sodium Granules, and Montelukast Sodium Oral Dissolving Film).

In the revised proposal for the Montelukast preparation instructions, a new "warning statement" has been added, mentioning severe reactions involving depression and suicidal tendencies. Neuropsychiatric adverse reactions have been reported in patients of all age groups taking Montelukast, including some severe reactions such as depression and suicidal tendencies; if the medication is not discontinued, these symptoms may persist. If neuropsychiatric symptoms occur during Montelukast treatment, the drug should be stopped and medical attention sought. Patients or caregivers are advised to be vigilant about neuropsychiatric adverse reactions and inform physicians if related symptoms occur during medication. The content on mental disorders within the adverse reactions should include "stuttering."

The original research drug Montelukast Sodium was developed by Merck & Co. of the United States and was first approved for marketing in 1998. It is a selective leukotriene receptor antagonist, mainly used to treat diseases such as asthma and allergic rhinitis. As an original research drug, after its patent expired, various generic drugs appeared worldwide.

On March 4, 2020, the U.S. Food and Drug Administration (FDA) issued information revising the Montelukast drug label to include a black box warning about its serious psychiatric adverse reactions and restricting its use.

On December 22 local time, a jury in Maryland, USA, ruled that Johnson & Johnson must pay approximately $1.56 billion (approximately RMB 11 billion) in compensation to a woman who developed cancer after using its baby powder product. The woman alleged that Johnson's baby powder contained asbestos, which caused her to develop mesothelioma. The jury found that Johnson & Johnson failed to warn the plaintiff about the risk of asbestos in its products and should be held responsible. On the 23rd, Johnson & Johnson stated that it would immediately initiate an appeal process. It is reported that litigation surrounding Johnson & Johnson's baby powder and other talcum powder products containing asbestos has been ongoing for 15 years, with this verdict setting the highest record for compensation awarded to a single plaintiff.

For years, lawsuits alleging that Johnson & Johnson's baby powder and other talcum products contain asbestos and cause cancer have hardly ceased. U.S. media reported that this is the highest compensation awarded to a single plaintiff in 15 years of ongoing litigation against Johnson & Johnson. Currently, Johnson & Johnson faces over 67,000 related lawsuits.

Recently, AliHealth signed a strategic cooperation agreement with Guangzhou Pharmaceutical Holdings Limited (GP). The two parties will focus on four core areas for in-depth cooperation: deepening platform and supply chain collaboration, jointly building a household expired medicine recycling system, exploring co-development of co-branded products, and promoting compliant data sharing.

Zhang Zehe, General Manager of AliHealth's Self-operated Division and General Manager of the Pharmaceutical Platform Business Unit, and Chen Jiehui, Deputy Party Secretary, Vice Chairman, and General Manager of Guangzhou Pharmaceutical Group, attended the event and witnessed the signing. Ni Kai, Head of AliHealth’s Commercial Procurement, and Cheng Hongjin, Deputy General Manager of Guangzhou Pharmaceutical Group, signed on behalf of both parties.

Zhang Ze, General Manager of AliHealth's Self-operated Business Division and General Manager of the Pharmaceutical Platform Business Division, pointed out that this collaboration marks a new phase where both parties move from sales synergy into comprehensive digital operation and full-chain service co-construction. He stated, "We will share insights, co-create new products, and integrate online and offline services, enabling Guangzhou Pharmaceuticals' high-quality products to reach millions of households across China more efficiently and precisely."

Chen Jiehui, Deputy Secretary of the Party Committee, Vice Chairman, and General Manager of Guangzhou Pharmaceutical Holdings Limited (Guangyao Group), stated in his speech at the signing ceremony that the pharmaceuticals industry is an everlasting "sunrise industry" with vast potential for future development. Through this strategic cooperation, both parties aim to create a new health ecosystem by integrating "pharmaceuticals + internet," aligning with the trend of digital economy merging with the real economy. He expressed hope that the two parties will continue to deepen their collaboration in the future, closely integrating products, brands, and services to allow more consumers to enjoy high-quality and convenient health services, thereby contributing to the construction of "Healthy China."

Guangzhou Pharmaceutical Holdings Limited (GPHL) is the world's first Fortune 500 enterprise with traditional Chinese medicine as its main business, and also the "chain leader" enterprise of Guangdong Province and Guangzhou City’s biomedicine industry. It has more than 30 member enterprises, including 13 China Time-honored Brands such as Chen Li Ji, Wong Lo Kat, and Cai Shan Tang, carrying over 12 national and provincial intangible cultural heritage items. With profound accumulation in pharmaceutical manufacturing, industrial chain layout, and brand influence, GPHL is currently accelerating towards the goal of becoming a world-class pharmaceutical and healthcare enterprise driven by the “modernization, technological advancement, digitalization, and internationalization” four-pronged approach.

In recent years, AliHealth has continuously strengthened its positioning as the "launchpad for new and specialty drugs," committing to provide global pharmaceutical companies with full-chain support from drug launches, channel development, to patient services. Currently, AliHealth has become a partner to thousands of pharmaceutical enterprises worldwide.