In 2022, the HKSAR Government promulgated and implemented the Law on Pharmaceutical Activities of Chinese Medicines and Registration of Proprietary Chinese Medicines (hereinafter referred to as the "Chinese Medicines Law") and established the Pharmaceutical Administration Bureau to create favourable conditions for the development of the Chinese medicine and health industry in terms of improving the legal system and system construction. The NMPA is committed to safeguarding and promoting public health, and is committed to implementing the development strategy of the Plan for Moderate Economic Diversification of the Macao Special Administrative Region (2024-2028) to promote and support the development of the healthcare industry in various aspects.
Macao's proprietary Chinese medicine registration system has advantages
The registration system of proprietary Chinese medicines in Macao has introduced a system for the review and approval of proprietary Chinese medicines that combines the theory of traditional Chinese medicine, human experience and clinical trials. On the other hand, the classic prescriptions stipulated in the Chinese Medicines Law not only incorporate the standards of the Mainland, but also treat Chinese medicine from other countries or regions as classic Chinese medicine compound preparations, which are suitable for a wider range of markets. As of 15 April 2024, the NMPA has received a total of 192 applications for registration of proprietary Chinese medicines (12 locally manufactured and 180 imported) from local, Mainland, Hong Kong, Taiwan, Japan, Thailand, Indonesia and Malaysia, of which 56 proprietary Chinese medicines have been registered.
Promote the launch and use of new drugs in Macao, and contribute to the development of medical tourism
In order to support and encourage the marketing of clinically innovative drugs in Macao, under the premise of ensuring the safety, effectiveness and quality control of new drugs, the NMPA has simplified the preconditions for new drug registration applications, which require new drugs to obtain marketing authorization in a country or region with new drug research and development capabilities (including Chinese mainland, Australia, Canada, the European Union, the United States, Japan, the United Kingdom and Switzerland) before they can apply for registration and marketing in Macao, that is, the new drugs must be regulated in the country of origin or source. This includes the need for the manufacturing process to comply with Good Manufacturing Practice (GMP).
From 2022 to 15 April 2024, the NMPA has approved 72 new drugs for registration and marketing in Macao in accordance with the law, covering a wide range of therapeutic areas, including malignant tumors, cardiovascular diseases, skin diseases, neurological diseases, infectious diseases, etc., of which 26 drugs are first-in-class.
The NMPA regularly publishes information on approved new drugs on its website
Promote regulatory innovation and promote the linkage development of the regional health industry
In order to promote the development of the Chinese medicine industry in the Guangdong-Hong Kong-Macao Greater Bay Area, the state has introduced a number of preferential policies, among which traditional proprietary Chinese medicines for external use marketed in Macao can be listed on the mainland after being simplified and approved by the Guangdong Provincial Medical Products Administration. At present, 2 pCms for external use manufactured and sold in Macao have been registered as drugs in the Mainland, and 1 pCm entered a tertiary public hospital in Zhuhai for clinical application in December 2023.
According to the policy of "Hong Kong and Macao Medicines and Medical Devices", drugs that are urgently needed for clinical use and have been marketed in Macao can be used in designated medical institutions in the Greater Bay Area after being approved by the Guangdong Provincial Drug Administration and the Guangdong Provincial Health Commission.
In order to promote the implementation of "Macao registration + production in Hengqin", the Food and Drug Administration issued the first pre-authorization for commissioned manufacturing in 2023, approving a Macao Chinese medicine pharmaceutical factory to entrust the production of proprietary Chinese medicines in the Guangdong-Macao Traditional Chinese Medicine Science and Technology Industrial Park, so as to implement the joint development of Macao-Hengqin traditional Chinese medicine.
With the support of the National Medical Products Administration, the Macao Food and Drug Administration and the Guangdong Provincial Medical Products Administration have achieved regulatory innovation and introduced five hospital preparations of Chinese medicine from Guangdong Provincial Hospital of Traditional Chinese Medicine to Macao hospitals for clinical application in October 2023. The NMPA will continue to promote the introduction of more Chinese medicine hospital preparations from the Mainland to Macao, so that Macao residents can also use the high-quality Chinese medicine resources of the Mainland for medical treatment in Macao, and encourage the industry to promote the transformation of potential Chinese medicine hospital preparations into new drugs through the collection of clinical use data.
The first batch of preparations prepared for mainland Chinese medicine hospitals arrived in Macao in October 2023
In addition, in order to further strengthen the close cooperation between Macao and the Mainland in the field of drug supervision, the Macao SAR Government and the National Medical Products Administration signed the "Cooperation Agreement on the Supervision of Drugs, Medical Devices and Cosmetics between the National Medical Products Administration and the Secretariat for Social Affairs and Culture of the Macao Special Administrative Region Government" on 7 May 2024, further developing and deepening cooperation in the field of drugs, medical devices and cosmetics on the basis of the cooperation agreement signed in 2019 in the field of drug supervision.
The Chief Executive, Mr Ho Iat Seng, witnessed the signing of the Agreement on Regulatory Cooperation on Drugs, Medical Devices and Cosmetics between the National Medical Products Administration and the Secretariat for Social Affairs and Culture of the Macao Special Administrative Region Government by the Secretary for Social Affairs and Culture of the Macao Special Administrative Region Li Li.
The Macao SAR Government will actively make use of the advantages of Macao's drug approval system to continuously improve drug supervision and management, and promote the development of the Chinese medicine and health industry.
Information and some photo sources: Pharmaceutical Administration Bureau