Medical network - on September 13, recently, by the state food and drug administration bureau, a senior research institute and shenyang pharmaceutical university international food and drug policy and law research center hosted the "drug marketing authorisation holder system advanced seminar", boehringer ingelheim Luo Guli biological pharmaceutical (China) co., LTD. General manager said: "the drug marketing authorisation holder system is expected to be into laws, MAH means in the national promotion, contract manufacturing business model will be opened in the country."
According to statistics, from the current accepts the main application for registration of the drug marketing authorisation holder, drug research and development institutions to declare accounted for more than 50%, the data suggest that system's implementation effectively stimulated the innovation of the r&d staff enthusiasm, bonus system preliminary revealed.
In August of this year, the state administration of found problems in the process of summarizing previous pilot, on the basis of published again the administration of pilot work on promoting drug marketing authorisation holder system matters related to notice, to further explore the holder of the rights and obligations and legal liability, commissioned in the production of quality management system, production and sales of ten aspects, such as the responsibility of the whole chain system, accelerate the pilot work holder system.
The system design is to hope that these innovative pharmaceutical enterprises can realize their invention value, thus further encourage developers to make more inventions and innovations. However, as an innovative enterprise applying for MAH, it is not only enjoying the dividend, but also facing great pressure. "As an innovative company, as a licensed drug listed licensee, it is responsible for the quality and safety of medicines," said luo. In theory, contract manufacturers need to be regulated. However, some of these enterprises are small teams of 10 or 20 people, how to supervise the quality management system of contract manufacturers?
Contract production is still to be completed
According to the reporter, contract production is a very mature business model in foreign countries, especially in Europe and America. Given that the fixed investment in drug production is very large, for a new product that has not yet been listed, such investment has a huge risk and will also burden the enterprise.
For a listed product, if the long-term occupation of the enterprise's capacity, will also affect the new product research and development and the listing. So in Europe and the United States and other countries, often to vacate basket in the way of birds, the plateau when the product enters the market, you can take the way of contract production, its own factories to develop new products.
Luo Guli said: "in fact, the entrusting party and the entrusted party is of common concern from production activities of the agency appointment contract, can guarantee the quality of the drug, MAH on the effectiveness of the drug, accessibility are the responsibilities of absolute including safety, because it is inherent risk part of drugs. The quality control of drug production, as well as the production cost and process, is the responsibility of the trustee. In terms of patient use, there are risks, how to relate these three aspects, and the need to explore a suitable solution.
Chinese medicine quality management association, vice President of ChangSunSheng new said: "in this case, to ensure drug safety, we need some recognized qualifications of MAH, we have to consider, MAH is really want to research and development of new drugs, or take the money, not only to the holder itself, and to evaluate their team, to confirm whether they have the ability to perform the corresponding responsibility. On the other hand, we need to establish a good commercial insurance system that allows insurance companies to restrict MAH to avoid MAH's inability to compensate, which can not protect patients' interests. Finally, in the process of our country development of MAH, should play the role of insurance companies and institutions of the third-party evaluation, contract manufacturer of MAH, entrusted professional assessment, assessment after the supervision department for the record, so you can take some risks."
As the contract production mode, from the perspective of supervision, the future is approved in the product, and the GMP supervision is mainly the production site. Therefore, CMO enterprises will be more demanding of themselves, because CMO must be a multi-product, multi-customer mode to improve their own profits.
In this regulatory context, once a product, process change discovers a warning or violation, the qualification of the entire plant will be questioned, and the enterprise will lose its living conditions. In this case, none of the world's fiduciary companies is willing to work with the principal to fabricate, or to produce a manufacturing process that is fake with a principal.
Luo jili from another point of analysis pointed out: "not only the client should audit the qualification of the agent, but the trustee will also review the qualifications of the client. On the one hand, we need to establish the mechanism from the Angle of regulation, on the other hand, the agent should also conduct a strict review of the client."
The CMO doesn't have "a lot of fragmentation."
Prior to MAH's implementation, although the principal of the trustee was the production enterprise, in China, there was no production enterprise that did not possess the drug in order to obtain the GMP certificate. But under the current regulations, the production of commissioned production still exists, and the contract production of export drugs has been flourishing.
It is because of the training of international markets that a lot of powerful enterprises emerge in this field, and there will be no "scattered chaos" pattern.
Domestic pharmaceutical industry development determines the current mature CMO focus small molecule chemical medicine, especially in chemical intermediates and apis, listed companies have all, bo teng, gloria Britain, the United States novartis, mainly to do the export business, this is also for Europe and the United States is listed the holder system, using DMF management API.
A hangzhou CMO do better for the people's livelihood, the enterprise passed the American FDA inspection, domestic after the pilot system of MAH, announced the first batch of Shanghai list there is a research and development enterprise AnBiSheng choose hangzhou minsheng MAH as ground plant application. Hangzhou australasia is the CMO that focuses on freeze-dried products, already has many domestic enterprises to entrust its production, also established freeze-dry technical training center, has become a leading enterprise in freeze-drying field.
At present, the CMO business of domestic preparation factory mainly comes from the export business in Asia and Africa, which is a direct price competition.
Many pharmaceutical companies are willing to take on cmos, but they are generally a strategy in which their products can't fill their spare capacity, not the core business of CMO.
Haimen hui poly pharmaceutical co., LTD. General manager zouping introduces the progress of the production company to carry out the contract, he said: "from 2003 to 2003, in fact, with foreign companies, we launched a dozen varieties of contract production.
With the implementation of the system of MAH, after supporting policies, only a year and a half, and we have new drug research and development of domestic enterprises, by means of contract manufacturing for more than a dozen production cooperation. Have two varieties in clinical Ⅲ period, the implementation of the policy, to the CMO industry development has brought the huge role."
It is worth noting that MAH, because of its focus on research and development, cannot simply replicate the technological route, and has higher requirements for the production process of CMO enterprises. If the pharmaceutical CMO enterprises take simple replication and not in-depth study on process optimization, the probability of production failure will be magnified.
Clinical drugs in recent years, the client often provide laboratory's product line basis, if there is no profound technical foundation of medical CMO enterprise to conduct a comprehensive and meticulous research, development and optimization, the enlarge production face failure is almost a certainty.
Therefore, pharmaceutical CMO enterprises can not only do processing plants, but also must undertake a series of technical research and development, process optimization, destructive experiment and parameter adjustment to ensure the smooth production of production.
From international experience, different medicine and CMO enterprise through constructing technology platform to develop new technology and new technology is the main means of marketing, one technology can be used in the production of a variety of drugs API industrialization, medicine CMO enterprise seeks to can fit with the technology of drugs, pharmaceutical company for order. The core competitiveness of subsequent orders through sales techniques is not limited.
As one of the world's largest producer of biopharmaceutical contract, boehringer ingelheim do contract manufacturing for the global top 20 companies, is currently in the global market sales of the 47 products recombinant protein products, 27 by boehringer ingelheim production.
Luo Guli stressed, "currently, the contract is the nature of the production itself more products, more customers, the fusion of the regulatory system, for a CMO enterprise, they need to face a lot of variables, each customer's situation is different, after all. As a contract manufacturer, the client needs to meet the requirements completely. Under such circumstances, contract manufacturers cannot stick to a rigid and rigid regulatory system, and must have a system of multi-products, multi-customers and supervisory functions.
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