"The approval process is very smooth and convenient, and today I finally got the mainland listing registration certificate, and Zhang Quan's pain oil can also be sold in mainland pharmacies in the future." On 31 December 2021, the Guangdong Provincial Drug Administration issued the first three varieties of Hong Kong and Macao traditional chinese medicines for mainland marketing registration certificates to three Hong Kong and Macao enterprises, including Zhang Quan Talus Oil from Macau, Hexing Huoluo Oil from Hong Kong and Purple Flower Oil. Among them, Zhang Quan's tetanus oil is the first time in Macao that a proprietary Chinese medicine has been approved for registration and listing in the mainland. Zhang Jianneng, chairman of Zhang Quan's Pain Oil Chinese Medicine Factory, happily holds the "freshly baked" mainland listing registration certificate, and he looks forward to opening up the mainland market and making the products known to more people.
"The approval of the first batch of traditional proprietary Chinese medicines for external use in Hong Kong and Macao on the mainland marks the smooth implementation and practical results of Guangdong Province's implementation of the national policy on the benefit of traditional Chinese medicine in the Guangdong-Hong Kong-Macao Greater Bay Area." According to Su Shengfeng, a member of the party group of the Guangdong Provincial Drug Administration, as of now, a total of 12 traditional chinese proprietary Chinese medicines for external use have submitted applications for listing in the mainland by 9 Hong Kong and Macao enterprises, and after the first batch of 3 varieties have completed technical review and approval, it is expected that the second and third batches of varieties will be approved in the first half of 2022.
In recent years, not many Hong Kong and Macao proprietary Chinese medicines have applied for listing and registration in the mainland, mainly because the registration management system of proprietary Chinese medicines in Hong Kong and Macao is different from that of the mainland, and many Hong Kong and Macao enterprises are not familiar with the registration and listing requirements of proprietary Chinese medicines in the mainland. In order to promote the high-quality development of the Chinese medicine industry in the Guangdong-Hong Kong-Macao Greater Bay Area, the State Drug Administration and other departments have formulated policies related to the innovative development of drug supervision in the Guangdong-Hong Kong-Macao Greater Bay Area, and the mainland listing and approval of traditional chinese medicines for external use in Hong Kong and Macao will be entrusted by the State Drug Administration to the Guangdong Provincial Drug Administration for implementation.
On 27 August 2021, the Guangdong Provincial Drug Administration issued the Announcement on Simplifying the Registration and Approval of Traditional Proprietary Chinese Medicines for External Use Listed in Hong Kong and Macao, which encouraged Hong Kong and Macao enterprises and expressed their full expectations for the policy. The Provincial Drug Administration also actively carries out policy publicity and consulting services to proprietary Chinese medicine enterprises in Hong Kong and Macao, and arranges special counseling for the problems and difficulties faced by different Hong Kong and Macao enterprises, and follows up and solves them one by one. Through early intervention before declaration, coordinate the research resources of drug inspection and safety evaluation in the Greater Bay Area, and provide corresponding technical support for Hong Kong and Macao enterprises. At the same time, taking the actual listing and use of traditional foreign drugs in Hong Kong and Macao as important evidence, we will strictly grasp the review and approval standards and not reduce them to ensure the quality of listed products in the mainland.
"After we learned of this policy, we submitted the application as soon as possible, and we also paid close attention to the progress, the approval process was simplified, and we successfully obtained the mainland listing registration certificate." Huang Haidong, chairman of Guangdong Henglinyuan Pharmaceutical Co., Ltd., the general agent of Hong Kong Purple Flower Oil, said that the next step will be to increase the publicity of products in the mainland, and it is also believed that more traditional chinese medicines for external use in Hong Kong and Macao will be listed on the mainland through simplified approval.
Guangzhou Caizhilin Pharmaceutical Co., Ltd. of Guangzhou Pharmaceutical Group is the general distributor of Hexing Huoluo Oil in Hong Kong. Wei Lijun, deputy general manager of the company, told reporters that many traditional proprietary Chinese medicines for external use in Hong Kong and Macao are quite recognized by mainland consumers, such as hexinghuoluo oil, which is responsible for sales in the mainland, with an average annual sales of 60 million yuan. "HexingHuoluo Oil, which obtained the mainland listing registration certificate this time, has sold well in Hong Kong and Macao and has a good reputation among mainland consumers. It is believed that after it is listed in major pharmacies in the mainland, sales will increase well. Wei Lijun also revealed that the company will have a further layout, and it is expected to introduce more traditional chinese medicines for external use from Hong Kong and Macao to the mainland market in the future.
Zhang Jianneng said that after obtaining the mainland listing registration certificate, he would discuss with the agent seller as soon as possible a cooperation plan for selling Zhang Quan's pain oil in the mainland. "Our products have a history of 60 years and have been sold in Hong Kong and Macao in the past, and I believe that after entering the mainland market this time, there will be greater sales potential." Simplifying the registration and approval of traditional proprietary Chinese medicines for external use that have been listed in Hong Kong and Macao is also a development opportunity that we Hong Kong and Macao enterprises cannot miss, which is conducive to our further integration into the development of the traditional Chinese medicine industry in the Guangdong-Hong Kong-Macao Greater Bay Area. ”
Su Shengfeng said that the Guangdong Provincial Drug Administration will continue to accelerate the review and approval of the registration and listing of traditional Chinese medicines for external use in Hong Kong and Macao, smooth communication channels, strengthen the tracking service of special personnel, and promote more high-quality traditional Chinese medicines in Hong Kong and Macao to register and list in the mainland; at the same time, under the guidance of the State Drug Administration, strengthen the docking with the registration review and approval mechanism of proprietary Chinese medicines with the drug regulatory departments of Hong Kong and Macao, gradually improve the registration review and approval capacity of proprietary Chinese medicines in Guangdong Province, and further optimize the approval process. Provide more convenience for Hong Kong and Macao enterprises and release more dividends for the innovation and development of drug supervision in the Guangdong-Hong Kong-Macao Greater Bay Area.
[Reporter] Zeng Meiling
[Correspondent] Cantonese Drug Administration
【Author】 Zeng Meiling
【Source】 Southern Press Media Group South + client
Source: South+ - Create more value
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