Medical network - on December 23, recently, by the state food and drug supervision and administration of taxation and the guangxi zhuang autonomous region people's government hosted the fourth china-asean drug in the western Pacific region cooperation development peak BBS and herbal coordination BBS held in nanning. The BBS with "improving the quality of generic drugs" as the theme, to discuss the way of drug regulation of international development, seeking to build China's drug regulators and the association of south-east Asian nations (asean) and the area along the country's regulatory cooperation platform.
As important medical market in the world, China's largest producer of generic drugs, generic drugs become the main force of pull global drug sales growth. However, the generic drug development of our country faces a "consistency evaluation", multiple problems such as uneven quality. Delegates to think, should constantly improve the medicine scientific research ability, comprehensively improve the quality of generic drugs, for Chinese medicine to enter the international market to lay a more solid foundation.
China generics gradually received international recognition
Wu zhen, deputy chief of the state food and drug supervision and administration bureau, said after the long-term efforts, generics industry has gradually been recognized by the international and China now has more than 300 active pharmaceutical ingredients and 40 preparations were allowed to go on sale in the United States, 25 apis and 17 preparations for the world health organization (who) certification, the generic drugs made in China is gradually entering the international mainstream pharmaceutical market.
"Generic drugs is not the original medicine of fake products, but a replica of the original drug, and the original drugs in specifications, dosage forms, usage, dosage, quality control, and the same curative effect, can completely replace the original medicine." Wu said, all countries in the world to encourage and develop generic drugs, through effective, safe and cheap generics, lower drug prices, improve drug accessibility.
The delegates agreed that compared with the original drugs, generic drugs research and development time is greatly shortened, economic investment is greatly reduced, so the price is lower than the original. Generics with lower medical expenditure, improve the medical service level, improve the drug accessibility and affordability and other important economic and social benefits, to solve the problem due to financial hardship do patients medication distress situation provides a new way of treatment.
China's pharmaceutical industry was basically the imitation, imitation and combined with phase. As early as in 2007, the revised "drug registration management method", the drug regulatory agency in our country requires that, whenever the domestic market have branded drugs, generic drugs must be compared with the original drug, otherwise it will not be approved. At present, our country can produce more than 1600 in global more than 2000 kinds of chemical pharmaceuticals, chemical agents more than 4500 varieties, annual output of more than 1 billion vaccine doses.
The state food and drug administration and data statistics show that in the field of pharmaceutical industry, 2015 to 2015, a total of pharmaceutical enterprises in our country, the current sales enterprises 46.6, pharmaceutical industry output value 2.8 trillion yuan. Wu said that China has a strong and complete production capacity, at the same time of guarantee their people's medical needs, can also provide support for asean countries such as the people's health.
Consistency evaluation into generics development bottleneck
Delegates to analysis, at present the generic drugs and there are certain gaps when compared with the original medicine equivalence, the biggest problem is "consistency evaluation". Generics is not only in our country there is a gap with the original drugs, even with generics in other countries there is a certain gap.
RDPAC (research and development of pharmaceutical enterprises association) represent, astrazeneca China President wang lei said the main problems of generic drugs in our country are numerous but are of variable quality, curative effect is significant difference compared with the original drug. At the same time, there is excess capacity, disorderly and vicious competition, bad money after bad money problems, let patients and doctors to lose confidence in the curative effect of generic drugs.
Wang lei said, because there are many differences different manufacturer of active pharmaceutical ingredients, generics in dissolution, distribution, absorption, metabolism, stability and security, and so on with the original drugs may vary, thus affecting the curative effect of generic drugs.
"Because of the original drug preparation process shrouded in secrecy, generic drugs can only according to the composition of prescription and drug delivery approach, preparation technology was studied and validated on its own." A drug firms, says to the reporter, head of the generic drug preparation process is not yet mature relatively.
In addition, in terms of market access, generic drugs need to be with the original drugs have the same can only be listed after the bioequivalence. At present, our country many generic drugs research and development of reference preparation does not exist in the process of the unification, such problems as incomplete bioavailability study, lead to the quality of generic drugs, security, bioequivalence in doubt.
In the face of the multiple problems, to carry out the consistency evaluation becomes the key to generics breakthrough. Delegates to think that, with the development of the consistency evaluation in our country, the research of the quality of generic drugs is from standard of "copy" to "imitation products (the original drugs), only in this way can ensure the quality and efficacy of generic drugs in accordance with the original drug.
For consistency evaluation of bioequivalence in clinical trials, drug clinical trial institution will be the more important one annulus. The drug companies on behalf of the report, for the moment, looking for clinical trials of medical institutions is the most urgent, "great difficulty".
Biological pharmaceutical co., LTD., vice President of Beijing world bridge Liu Yali said, now the clinical experiment project, more time and heavy task, a shortage of clinical resources. After the implementation of records, new institutions to develop bioequivalence test may experience deficiencies, multidisciplinary contact is not enough, medical personnel to participate in such problems as too late, and consistent evaluation process is a system engineering, even in a foreign country clinical trials of the success rate is less than 80%, so the inspection and quality control of clinical trials is much more important.
Consistency evaluation of future prospects
"In strictly grasp the marketing authorisation at the same time, the state food and drug supervision and management of the administration is launching a consistency evaluation of generic drugs already on the market, the listed drugs compared with the original medicine and international recognized drugs, in the quality and curative effect can be achieved with the original drug instead." Wu said that the work is not unique to China, the United States in the 1960 s, Japan in the 1990 s have carried out a similar job.
As early as in 1984, the United States has issued the Hatch - Waxman amendment, namely the drug price competition and patent phase compensation law amendment. The FDA (food and drug administration) to China office Dr Jennifer may jean said at the meeting, deputy director of the drug in the treatment of equivalent when is fungible, equivalence and bioequivalence equivalent including drug treatment, the amendment to the United States the development of generic drugs not only path, also gives enlightenment to other countries.
In 2007, Japan also launched the "generics can use promotion action plan". Japan's independent administrative legal drugs medical equipment integrated organization deputy executive director sato YueXing said at the meeting, the government needs to compress medical insurance expenditure, patients need to reduce your payment amount, insurance amount bears need to reduce spending, greater use of generic drugs should be able to achieve lower drug costs and improve efficiency.
Wu said that to carry out the consistency evaluation can promote the reform of medicine industry structural supply side, to promote structural adjustment and industrial upgrading and improving people's livelihood, power has important significance to speed up the construction of medical industry. Consistency for promoting quality of generic drugs and curative effect evaluation, the general office of the state council in March of this year issued by the consistency on the quality of generic drugs and curative effect evaluation of opinion ".
Opinions, points out that through consistency evaluation of drug varieties, in terms of payment shall be properly supported, medical institutions should be prior purchasing and preferable in clinical; With varieties of drugs through consistency evaluation of manufacturing enterprises to achieve more than three, in such aspects as drug centralized purchasing no longer choose not through consistency evaluation of varieties; Through consistency evaluation of the technical renovation of the pharmaceutical production enterprise in accord with relevant condition, can apply for the central infrastructure investment, the industrial fund and so on.
In addition, to encourage enterprises to promote the work, the state food and drug supervision and administration bureau set up the consistency evaluation office, has been issued on the implementation of the state on matters related to the announcement of 10 jobs such as files and the common reference preparation oral solid preparations to select and determine the guiding principles and five guiding principles, there are four guiding principles for public opinion. At the same time, around the industry reference for preparation, application of varieties, evaluation method, across the country to carry out free training, and set special column and update on the portal website, information open and transparent.
Administration of state food and drug supervision and administration of drug registration SiYang wins said at the meeting, before the end of 2018 to 289 varieties of complete consistency evaluation, including 17636 of the 104 document of approval for domestic and imported drug registration certificate, involved 1817 domestic drug manufacturing enterprises and 42 foreign pharmaceutical enterprises. |
