Recently, the State Food and Drug Administration issued the "Notice on Simplifying the Registration and Approval of Traditional Oral Chinese Patent Medicines Already Marketed in Hong Kong and Macao for Market Registration in the Mainland (Draft for Comments)" (hereinafter referred to as the "Draft for Comments"). The registration and approval of traditional oral Chinese patent medicines in Hong Kong and Macao in the Mainland is expected to be further simplified, and the technical review period for qualified varieties will be shortened from the conventional 200 working days to 80 working days.

▍Key points analysis
The "Draft for Comments" clearly states that the relevant applicant companies and varieties must meet three conditions at the same time: traditional oral Chinese patent medicines held by local registered manufacturers in the Hong Kong and Macao Special Administrative Regions, approved for market listing by the Hong Kong and Macao Special Administrative Regions' drug supervision and administration departments and used in the Hong Kong and Macao Special Administrative Regions for more than 15 years, their production process must comply with the requirements of Good Manufacturing Practice (GMP) for pharmaceutical production.

The "Draft for Comments" proposes the division of responsibilities of relevant units. First, the Greater Bay Area Center for Drug Evaluation and Inspection of the National Medical Products Administration assists the Drug Evaluation Center of the National Medical Products Administration in accepting and reviewing applications for marketing authorization, post-marketing changes and re-registration of such products. Second, the Guangdong Provincial Drug Administration undertakes drug registration inspection (including standard review and sample inspection) and conducts drug registration verification or drug production quality management specification compliance inspection in accordance with relevant overseas inspection regulations. After the acceptance, review and inspection work is deployed to the Greater Bay Area Center and the Guangdong Provincial Drug Administration, it not only consolidates the local regulatory responsibility and mobilizes its enthusiasm, but also improves the work efficiency and time limit to a certain extent.

Regarding the requirements for listing applications and application materials, the content of the "Draft for Comments" shows that: First, a corporate legal person in the Mainland (hereinafter referred to as the applicant) should be designated to handle relevant drug registration matters. Second, the experimental research materials submitted when it was originally listed in the Hong Kong and Macao Special Administrative Regions can be used as the corresponding application materials. According to the variety, the applicant can provide a summary of its human experience in use for 15 years on the market, and if there is any drug clinical trial data and non-clinical safety test data that have been approved by the Hong Kong and Macao drug regulatory authorities, it can also be provided. According to the "Classification and Application Materials Requirements for Registration of Traditional Chinese Medicines" and "Special Regulations on Registration and Administration of Traditional Chinese Medicines", overseas traditional Chinese medicines applying for domestic listing must submit application materials as innovative drugs. General requirements: Application materials are usually organized in accordance with the requirements of "M4: Common Technical Documents (CTD) for Registration of Human Drugs". Specifically include the following aspects: administrative documents and drug information, summary, pharmaceutical research materials, pharmacological and toxicological research materials and clinical research materials. In comparison, the application materials required for traditional oral Chinese patent medicines that have been listed in Hong Kong and Macao that meet the announcement are indeed much simpler than those required for other overseas listed Chinese patent medicines.

From the perspective of review requirements, the "Draft for Comments" adjusts the review period from 200 days to 80 days. In addition, the post-marketing research and evaluation work that the applicant needs to complete before the next re-registration application is clearly stated in the approval conclusion of the drug registration certificate. Those that are not completed on time will not be re-registered. Such adjustments mean that the efficiency of the review process will be improved, allowing related drugs to complete the review process faster, accelerate their entry into the market or the progress of subsequent processes, and reduce the waiting time for applicants.

▍Big changes in oral Chinese patent medicines
According to the "Chinese Medicine Ordinance" in the registration system of Chinese patent medicines in Hong Kong, "Chinese patent medicines" must apply for registration with the Chinese Medicine Board of the Chinese Medicine Council of Hong Kong. For Chinese patent medicines manufactured, sold or supplied for sale in Hong Kong on March 1, 1999, local manufacturers and local importers of foreign-made Chinese patent medicines can apply for transitional registration from December 19, 2003 to June 30, 2004. If they meet the requirements and submit basic information to protect public health, they can obtain a "Confirmation of Transitional Registration of Chinese Patent Medicines" and be deemed to have obtained non-transitional (formal) registration, and the relevant number must be marked on the outer box label. The "Confirmation of Transitional Registration of Chinese Patent Medicines" began to be issued on March 31, 2008. For Chinese patent medicines holding this notice and newly submitted registration applications, the Chinese Medicine Board will review them as required. If they meet the safety, quality and effectiveness requirements, they will be approved for registration and issued a "Chinese Patent Medicine Registration Certificate" with the corresponding number. Therefore, the earliest date of issuance of the certificates/notices collected and displayed by the Chinese Medicine Council of Hong Kong is March 31, 2008.

At present, the total number of Chinese patent medicines listed in Hong Kong, China is 8,182, of which 5,031 have been on the market for 15 years or more. There are 1,979 Chinese patent medicines with oral administration, accounting for 39.3%. It is not difficult to see from this data that oral preparations account for a considerable proportion of Chinese patent medicines listed in Hong Kong for more than 15 years. Through the collection of Chinese patent medicines listed in Hong Kong by Yaozhi Data, according to the statistics of listed varieties, we can get the top 10 Chinese patent medicine companies in Hong Kong and the top 10 Chinese patent medicine varieties listed in Hong Kong.

As of the date of publication, the number of Chinese patent medicines listed in the mainland of Hong Kong is 48, covering a total of 7 dosage forms. Under the policy framework that has been implemented in the past to simplify the registration and approval of traditional external Chinese patent medicines that have been listed in Hong Kong and Macao, a phenomenon can be found: the number of traditional external Chinese patent medicines in the market has shown a very prominent trend.

If the "Draft for Comments" can be implemented, it will open up a more convenient listing channel for oral Chinese patent medicines in Hong Kong and Macao, and attract more oral Chinese patent medicines to smoothly enter the circulation field of the mainland market. For Hong Kong and Macao pharmaceutical companies, the mainland market is like a blue ocean full of potential. They can take advantage of the policy to conduct in-depth research on the mainland market demand and regulatory details, accurately position products, formulate appropriate market strategies, and actively carry out cooperation, so as to occupy a place in the huge mainland market and achieve a double harvest of their own brands and benefits.

For the mainland market, this is both an opportunity and a challenge. The policy will introduce more traditional oral Chinese patent medicine products from Hong Kong and Macao, enrich the market supply, stimulate the vitality of industry competition, and encourage mainland pharmaceutical companies to continuously improve their own research and development and management levels.
In the future, driven by this policy, the Chinese patent medicine markets in Hong Kong, Macao and the Mainland are expected to work together to advance and create brilliance, inject strong impetus into the development of Chinese medicine, and allow the traditional Chinese medicine treasures to shine more brightly in the new era.

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