Details of the drug listing licensing system (MAH).

core of the drug market licensing system (MAH) is the separation of drug approval numbers and production licenses, allowing pilot drug research and development institutions and researchers to obtain drug approval numbers, and assuming corresponding responsibility for drug quality. Before the introduction of MAH, our country is the implementation of the listing license and production license unified bundled management model, only the production enterprises can apply for drug registration, access to the final drug approval number.backgrounddomestic background
before the introduction of the MAH system, China also has a similar system: entrusted production system and technology transfer system.
It is worth noting that the commissioned production system is not the only access system under the production license and listing license, according to the current provisions of the commissioned production, can only entrust the production enterprises with this approval number of the enterprise to the outside, but also the entrusting party and the trustee are production enterprises, and their own approval number is not changed with the entrustment. It can be said that the commissioned production itself is only in the holding enterprise has technological transformation and other temporary arrangements without production conditions.
The technology transfer system is based on pharmaceutical production enterprises, the application of drug technology transfer is divided into three situations: 1, some new drugs, preparations and raw materials for transfer;international background
MAH has long been widely used in the international community, the mainstream developed countries and regions generally adopted the drug market licensing system.
separate system of listing management adopted by the European Union, which is applied for separately by MAH and PLLH, MAH can also produce its own products or entrust the products to different manufacturers. Production enterprises are only a part of the declaration, and after receiving the declaration, the competent departments alone on-site verification of production enterprises and GMP different circumstances of the review and certification.
the U.S. and the European Union, any conditional subject can file a declaration with the FDA, and the producer's separate rule is that MAH is not restricted from acting as a drug manufacturer at the same time. The FDA also conducts a separate review of manufacturers and determines requirements for sampling product facilities, among other aspects, in the approval process for drug licensing.
Since 2005, Japan has also adopted a listing licensing system that separates listing and production, but it is characterized by its own innovative creation of a listing license system, which means that he has a MAH access prerequisite, only after obtaining the first administrative license qualification, before the drug can be applied for to market. At the same time, it also has some special provisions, first of all MAH must have some of the main management responsibilities of the post settings, including sales management subjective, quality assurance subjective, listing safety control subjective, three have a certain qualification of full-time management functions.MAH system advantages First, mobilize the enthusiasm of drug research and development institutions and researchers research
AFTER the introduction of the MAH system, the property rights of scientists to develop drugs will be used to belong to the holders, which will also attract more researchers into the new drug research and development team, improve China's pharmaceutical research and development strength, change the past generic drugs "imitation is not strong" embarrassing situation.Ii, conducive to the adjustment of industrial structure and allocation of resources, promote professional division of labor, improve industrial concentration, avoid duplication of investment and construction
Because they are not willing to change their varieties to other manufacturers, but also hope that their own varieties can be listed, many pharmaceutical companies often choose to build a factory for a variety. After the introduction of the MAH system, pharmaceutical companies can entrust enterprises with production conditions to produce, so as to focus on their respective expertise in the division of labor.Three, conducive to the implementation of the main responsibility of enterprises
in some drug-harm incidents, pharmaceutical production enterprises, operating enterprises, medical institutions and even research and development institutions are difficult to define the responsibility, so that there is mutual involve, mutual constraints, victims have been slow to get a fair solution. After the introduction of the MAH system, the drug market license holder is the responsible subject of the product, any problems of this product, all chain links are responsible for it.Seven, conducive to avoiding the risks in the research and development process
drug research and development there are many risks, and even many new drugs have been on the third phase of clinical, only to be proved to have no exact efficacy, which is very heavy for pharmaceutical companies and investors. Because, under the current registration management method, the pre-investment needs: before reporting production, the entire research and development in the application for production to have the corresponding drug production conditions, the entire workshop, equipment should be installed in place, at the same time, also need hardware input, including software, personnel, equipment matching and so on. Once in the variety before the market any wind and grass movement, investment will be water drift, these equipment will also be because it did not put into production in time to be empty, until the next round of drug review, the equipment will most likely have to be updated, re-purchased.5, conducive to the protection of the safety of drug users
in the State Council issued the program, the name song stipulates that in the course of drug use, as long as adverse reactions or adverse events, patients can to the production enterprises or holders or operating enterprises, to either party to claim, head count, and finally by their three parties to carry out the quality of this product in the end belong to which party, in the holder system for the legitimate rights and interests of drug users is maximized protection.MAH Trial Rules Interpretation
The trial scope of the drug listing license holder system includes Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, Sichuan 10 provinces (cities), of which in accordance with the overall deployment, the actual introduction of Beijing and Shanghai, the system is relatively perfect.Key Positions
Pilot Program also has research and development institutions and individual research and development personnel can apply, but considering the need to match individuals, the draft itself mentioned some key personnel settings, such as quality officers, safe pedestrians and other key positions in the final draft of the pilot program is not reflected.application conditions
Beijing requires a residence permit, but Shanghai only requires a work address. In terms of joint applications, Beijing requires that if there are more than one individual to apply, it is necessary to register a person as the holder, and there is a requirement for the election of representatives. But Shanghai currently has no clear rules on this piece. Special
Beijing stipulates that special drug preparations must be produced by enterprises in the city, and the trustees must not be outside Beijing. Shanghai requires that for sterile supplies, reverse preparation requirements must be commissioned in Shanghai. Obligation Liability
Beijing requires holders to sign quality agreements with entrusted manufacturing enterprises, to have new responsibilities for improving the quality of drugs, and to refine the evaluation responsibilities and recalls after the listing. Shanghai requires the establishment of a quality management system covering quality-related factors to interface with subsequent production and sales, and there are some very detailed requirements for the establishment of all the specific requirements of the system.
the responsibility of the entrusted production enterprises, Beijing has increased the obligation of the entrusted enterprises to inspect records and archive backups, and has also stipulated that unauthorized disposal and sale cannot be carried out without the consent of the holder. In terms of supervision and management, regulators are required to strengthen strict pre-listing reviews. faq,
1, can the holder hold two or three shares? Can the holder entrust more than one enterprise to produce?
: At present, in order to clarify the subject of responsibility, the holder can only be one, on a variety can only be one holder.
at present, our country's commissioned production methods also do not limit the commissioned production can only be entrusted to one, you can entrust more than one.
2, to clarify the joint declaration of multiple applicants, can they jointly hold the document number?
: The approval number can only be one person.
3, the main body of approval of the pilot work is the General Administration or the provincial bureau?
: Is currently accepted by the General Administration, the State Bureau for approval.
4, the original declared varieties of clinical raw materials and preparations are now to submit a separate API, increase the listing license holders of supplementary applications, is it possible to accept? Two dosage forms inside a separate application as a raw material for the listing holder OK?
: Yes. The policy is very flexible.
5, is it allowed to change the eligible "invisible holder" of listed varieties to a legal holder?
: This is the state is very non-advocacy, so-called invisible holders, your legal holders will be in accordance with the existing varieties and the scope of the provisions to follow the procedures.
6, production and packaging operations can be delegated separately?
: We're not allowed at the moment. Of course, we also put forward, in fact, we have a lot of imported sub-packaging, in many imported drugs in the production and packaging process is separate, for our listing licensee is not allowed.
research and development institutions established in China, foreign researchers holding "China Green Card" can become applicants?
: It's not okay to have a green card, but it's okay to set up a foreign agency. (Bio Valley)