The National Medical Products Administration (NMPA) has released two implementation plans aimed at supporting Hong Kong and Macau drug marketing authorization holders and medical device registrants to produce drugs and devices in nine mainland cities within the Greater Bay Area. These initiatives allow drug Marketing Authorization Holders (MAHs) and device registrants from Hong Kong and Macau to entrust mainland manufacturers in the Greater Bay Area for production.
Regulatory Oversight
The Guangdong Medical Products Administration will be responsible for production supervision, licensing, and registration related to the entrusted manufacturing and inspection of relevant companies within its jurisdiction. This includes overseeing the production of drugs and devices approved for marketing in mainland China by Hong Kong and Macau – based companies.
Scope of Application
The plans cover traditional Chinese medicine and chemical drugs owned and manufactured by legally registered companies in Hong Kong or Macau, excluding those prohibited from entrusted manufacturing under the Pharmaceutical Administration Law of the People’s Republic of China and the “Measures for the Administration of Precursor Chemicals in Pharmaceuticals” (Former Order No. 72 of the Ministry of Health). For medical devices, all devices owned and manufactured by legally registered companies in Hong Kong or Macau and approved for marketing in mainland China are eligible, except those listed in the “Catalogue of Medical Devices Prohibited from Entrusted Production” (Announcement No. 17 [2022] of the NMPA).
Liability and Obligations
The mainland enterprise legal person designated by the MAHs of Hong Kong and Macao in the Guangdong – Hong Kong – Macao Greater Bay Area is required to fulfill the obligations of the MAH and bear joint and several liabilities with the relevant holders in Hong Kong and Macao. For medical device registrants, their foreign – invested enterprise legal persons established in the Greater Bay Area will act as agents to handle the registration of medical device changes, assist in fulfilling obligations under Article 20 of the Regulations on the Supervision and Administration of Medical Devices, and undertake joint liability.-Fineline Info & Tech
