Lei Jufang: Drug registration regulations do not align with the development of Tibetan medicine.

　　With the gradual increase in macro-level support for the development of ethnic medicine, Tibetan medicine is also embarking on a path of innovation.

　　On the afternoon of March 2, Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Qizheng Tibetan Medicine, provided the following proposal to reporters from the Daily Economic News: Regarding drug registration, Lei Jufang believes there is still room for adjustment.

　　Specifically, in recent years, Tibetan medicine has made limited progress in innovative development. In particular, it has encountered numerous challenges in terms of dosage-form innovation and regulatory registration applications. The main issue lies in the mismatch between the requirements of pharmaceutical registration regulations and the actual conditions of Tibetan medicine’s development, resulting in a scarcity of innovative Tibetan medicinal products and a limited variety of dosage forms.

　　According to data provided by Lei Jufang, according to Tibetan medical theory, there are more than 400 types of clinical syndromes and tens of thousands of commonly used prescriptions. In reality, only 146 varieties of clinically used medicines have been approved by the state. Over 97% of Tibetan medicinal products are in the form of pills or powders. Tibetan proprietary medicine pills face common technical challenges. Many of these products not only fail to adapt to modern lifestyles but also struggle to meet the relevant requirements of national regulations.

　　According to current review requirements, any change in dosage form must demonstrably improve either efficacy or safety. However, for certain dosage-form modifications aimed at enhancing patient compliance—for example, converting large, dark, and hard pills into tablets that better suit the medication-taking habits of mainland Chinese patients—it is often difficult to meet these review criteria. Moreover, due to certain sensitivities and methodological issues in animal studies, many topical patch formulations that readily induce allergic reactions in clinical settings may not necessarily show signs of irritation or allergy in animal experiments. As a result, it becomes challenging to reformat such products into less allergenic dosage forms—such as aerosols—as required by the review standards. Consequently, despite the efforts made by Tibetan medicine enterprises to adapt their dosage forms in response to industry needs, very few such reformulated products have been approved to date.

　　In addition, the national science and technology authorities encourage secondary development of large-scale medicinal products with proven efficacy. For Tibetan medicine, given its weak industrial foundation, there are even fewer large-scale products available, and thus fewer opportunities for reformulating these established products. Therefore, from the perspective of supporting industrial development, it is especially important to give appropriate priority to the secondary development and reformulation of large-scale products that already have a solid market base, thereby promoting the rapid and healthy growth of the Tibetan medicine industry.

　　Furthermore, many Tibetan medicines treat a wide variety of conditions, which also increases the difficulty of registering these drugs.

　　Due to characteristics such as the pharmaceutical theoretical system, cultural environment, and drug formulations, many Tibetan medicines treat a wide range of diseases. According to the Regulations on Drug Registration Management, when applying for new drug registration, all the primary indications and therapeutic uses of the original product must undergo clinical trials. Most Tibetan medicines have seven or more primary indications and conditions; if clinical trials are to be conducted, under current regulatory requirements, completing clinical trials for each indication would demand substantial funding and take an extremely long time—resources that many companies simply do not possess. In reality, some of these conditions may not even be the primary indications for which the product is intended; many products primarily target just one or two specific conditions, while other conditions listed were prevalent many years ago and no longer exist today.

　　Lei Jufang suggested that we might consider screening and approving the indications and main therapeutic effects of Tibetan medicines. For example, if a particular variety has eight indicated conditions, in order to reduce the burden on enterprises and encourage their innovation enthusiasm, during the approval process, enterprises could select 2–3 of these indications for clinical studies. When approving the official indications and main therapeutic effects, only those approved based on the results of the clinical studies would be recognized; the remaining indicated conditions could be gradually added to the approval list through future verification and validation.

　　The stringent requirements for pharmaceutical excipients in drug review have hindered the innovation process of Tibetan medicine.

　　With the strengthening of national drug regulatory oversight, requirements for pharmaceutical excipients have also become more stringent. Excipients added to pharmaceutical products must undergo experimental verification, primarily because some new excipients can affect the “activity” of the active pharmaceutical ingredient.

　　Traditional Tibetan medicine is typically prepared using whole medicinal powders with minimal use of excipients. However, when modifying the dosage form—for example, converting Tibetan medicine pills into tablets—the proportion of excipients involved is less than 3%. According to pharmacopoeial regulations on tablet weight variation, a 3% excipient content falls within the acceptable range. Moreover, the excipients used—such as medical modified starches designed to prevent sticking, plasticize the formulation, and enhance tablet hardness—are entirely harmless and do not affect the properties of the active ingredient nor pose any health risks to humans. Requiring validation tests in similar Tibetan medicine applications would impede the progress of innovative research and development in this field.

　　Therefore, during the routine formulation changes of Tibetan medicine, excessive consideration of excipient issues should be avoided, and some validation experiments should be reduced or eliminated.

　　The reporter learned that at the Two Sessions in 2015, Lei Jufang’s latest proposal suggested that the state should, based on the unique characteristics of Tibetan medicine, establish technical review thresholds that are suited to the current realities of Tibetan medicine development. It also called for greater support for industrial innovation in Tibetan medicine and encouraged the reformulation of classic Tibetan medicinal products and major varieties that have shortcomings in their existing dosage forms. In the routine process of modifying the dosage forms of Tibetan medicines, certain validation experiments involving excipients could be exempted or reduced.

　　In future clinical trials for new Tibetan medicines, based on the actual characteristics of each product, a selection of specific indications should be made for submission and approval. This process should be implemented in stages to accelerate the innovation process.

　　News source: Daily Economic News

　　News link: http://www.nbd.com.cn/articles/2015-03-02/900002.html