搜索
Search
这是描述信息
这是描述信息

news

Check category

·  news

Lei Jufang: drug registration regulations do not coincide with the development of Tibetan medicine

  • Time of issue:2015-03-03 18:13
  • Views:

(Summary description)

Lei Jufang: drug registration regulations do not coincide with the development of Tibetan medicine

(Summary description)

  • Categories:company news
  • Author:
  • Origin:
  • Time of issue:2015-03-03 18:13
  • Views:
Information

Lei Jufang: drug registration regulations do not coincide with the development of Tibetan medicine

Source: Daily News

With the macro-level support for the gradual development of national medicine, Tibetan medicine has also embarked on the road of innovation development.

March 2 in the afternoon, the CPPCC National Committee, chairman Lei Jufang Qizheng Tibetan Medicine to the content of the proposal, "Daily News" reporter in the display, for drug registration level, adjustable Lei Jufang think there is space.

Specifically, in recent years, Tibetan medicine in terms of the pace of innovation and development of small, especially the issue of innovation and product registration forms encountered more, mainly reflected in the relevant requirements, drug registration regulations and the actual situation of the development of Tibetan medicine do not coincide, so that Tibetan innovative varieties less, a single dosage form.

Lei Jufang according to the data provided, according to Tibetan medicine theory, there are 400 kinds of clinical conditions, there are tens of thousands of commonly used prescriptions. In fact, approved by the State commonly used in clinical medicine 146 varieties. Tibetan variety is more than 97% of pills, powders. Tibetan medicine pills exist common technical problems. Many products can not meet modern people's lifestyles both, and difficult to meet the requirements of national legislation.

According to the current review of the requirements of the dosage form for changing requirements significantly improved efficacy or safety. But for some increase patient compliance for the purpose of change agents, such as large, dark, hard ball into the habit of taking the tablets for the mainland it is difficult to meet the requirements of such a review. Due to the sensitivity of some methodological issues and animal experiments, many clinical allergenic plaster formulations in animal experiments do not necessarily manifested irritation and allergies, so it is difficult to change in accordance with the requirements of the review of other dosage forms such as hypoallergenic aerosol and the like, which leads to Tibetan medicine enterprises in the industry needs to adapt to changes made in the dosage form varieties, has approved the same.

In addition, the national science and technology sector to encourage the exact effect of a large variety of secondary development. Tibetan medicine, because of weak industrial base, a large variety of fewer opportunities for a large variety of change agents and even less so should support industrial development from the perspective of market-based secondary development of a large variety of good change agent proper inclination to promote Tibetan medicine industry rapid and healthy development.

Looking further, many more Tibetan attending disease, also increased the difficulty of registered drugs.

Since the theoretical system of medicine, culture, environment, drug prescriptions, etc., many Tibetan attending illness more. According to Drug Registration Regulations, when applying for registration of new drugs, and all the main medical indications original varieties are required for clinical trials. Most Tibetan indications and disorders in 7,8 or more, if clinical trials, according to the current regulations, a condition to complete clinical trials need large sums of money and a long time, many companies simply do not have the ability. In fact some disorders may not be the main medical products, play a role in many varieties, there are some disorders are a lot of historical conditions on one or two symptoms, and now no longer exists.

Lei Jufang proposed, can be considered for the Tibetan Indications screening approval, for example, an eight varieties adapt to the disease, in order to reduce the burden on enterprises, promote enterprise innovation initiative, select 2-3 adapt when conditions for approval clinical studies, when approval is only Indications according to the function performed clinical studies approved indications, the remaining conditions to be attending future gradual increase verified approval.

Drug Evaluation in pharmaceutical excipients requirements are too stringent, hindering the innovation process of Tibetan medicine.

With the strengthening of the national drug supervision, pharmaceutical excipients requirements are further strengthened, drug materials to be added to the experimental verification, mainly because some of the new materials for the main drug "vitality" influential.

Traditional Tibetan medicine production full of powder, almost no accessories, but in the process of changing the dosage form, will involve a number of accessories, such as Tibetan medicine pills tablets change, materials account for less than 3%, according to Pharmacopoeia tablet weight difference the provisions of 3 per cent within acceptable range, but the materials used are releasing, plasticizing, increase tablet hardness of medical starch, etc., it does not affect the nature of the main drug, harmless to the human body. If the Tibetan similar declaration requirements verification test, it will hinder the process of innovation and research and development of Tibetan medicine.

Thus, changes in conventional dosage forms of Tibetan medicine process, should not be too much to consider auxiliary problems should reduce some of the confirmatory experiments.

Reporters learned that the two sessions in 2015, the latest proposal Lei Jufang suggestion is, wants the state according to the characteristics of Tibetan medicine, Tibetan medicine is currently set up for the development of the technical review of the threshold of the actual situation, increase industry innovation efforts to support Tibetan medicine, encourage some forms flawed classic Tibetan breeds and varieties big change agent. Tibetan medicine in conventional dosage forms change process, a number of relief materials confirmatory experiments.

Tibetan new drugs in future clinical trials, according to the actual situation of the product, the partial screening adapt to the disease be declared and approved, should be implemented step by step, to accelerate the innovation process.■

relevant information

There is currently no information to display
Please add data record on website background.

CopyRightQizheng Tibetan Medicine Copyright ICP备案编号:陇ICP备18002323号-7  Internet drug information service qualification certificate number:(藏)Non-operational-2010-0002

TEL:0894-5826041 FAX:0894-5826076 Email:net@qzh.cn   Powered by www.300.cn