The core content of the Pharmaceutical Listing License of the holder (MAH) is the drug approval number and the production license abandonment，Pharmaceutical research and development institutions and researchers that allow pilot drugs to obtain the approval number of the drug，and bear the corresponding responsibility for the quality of the medicine。Before the introduction of mah，Our country has implemented a management mode for unified binding of listing licenses and production permits，Only manufacturers can apply for drug registration，Get the final drug approval number。

 

  Background

 

  Domestic background

 

  MAH system was promulgated，my country also has similar systems: commissioned production system and technology transfer system。

 

  It is worth noting is，Entrusted production system is not a product below the only access system for production permits and listing permits，According to the provisions of the current commissioned production，It can only entrust the manufacturer with this approval number to come to the commission，Also the commissioner and the trustee are all production enterprises，And the approval number of itself is not to be changed with the commission。It can be said，Entrusted production itself is just a temporary arrangement that does not have technical transformation under holding enterprises。

 

  The technical transfer system is based on pharmaceutical manufacturers，The application of drug technology transfer is divided into three: 1、Some new medicines、Delica and raw materials for transfer; 2、Imported registration to domestic production; 3、Including some transfers under the merger and reorganization and common control system，and the overall relocation My stake betting appor merging after the relocation，even give up all your own dosage form。

 

 International background

 

  MAH has already passed in the international community，mainstream developed countries and regions generally adopted a drug listing license holder system。

 

  The Listing Management Separation System adopted by the EU，Apply by MAH and PLH as the application，MAH can also be produced by yourself，You can also entrust the product to different manufacturers to produce。Production enterprises are just one part of the application，and after receiving the declaration，The competent department conducts on -site inspections and review and certification of different situations of GMP on the production enterprise alone。

 

  Similar to the United States and the European Union，Any conditionable subject can declare to the FDA，The separate regulations of the producer are not limited to MAH to serve as drug producers at the same time。During the approval process of the drug listing permit，FDA also reviews the manufacturer alone，Determined requirements for product facilities and other aspects。

 

  After 2005，Japan has also adopted a listing license system for listing and production，But it is characterized by its own innovative establishment of a system for listing licenses，That is to say, he has a MAH access prerequisite，Only after obtaining the qualification of administrative license，It can only be available for listing for drugs。At the same time, it also has some special regulations，First of all, MAH must have some positions of positions with major management responsibilities，Including sales management subjective、Quality guarantee subjective、Listing safety control subjective，Three full -time management functions with a certain qualification。

 

  MAH system advantage

 

  a、Move the enthusiasm of research and development institutions and researchers for drug research and development

 

  MAH system was introduced，The property rights of scientists develop drugs will be used to belong to the holder，This will also attract more scientific researchers to invest in the new drug research and development team，Improve my country's medical research and development strength，Change the embarrassing situation of the previous imitation pharmaceutical & quot; not strong & quot;。

 

  2、It is conducive to the adjustment of the industrial structure and resource allocation，Promoting professional division of labor，Improve industrial concentration，Avoid repeated investment and construction

 

  Current，Domestic drug manufacturers in my country、Small、San，This has a lot to do with the drug approval system。Because I don’t want to transfer my own Stake Sports Bettingvariety to other manufacturers，At the same time, I hope that my variety can be listed，Many pharmaceutical companies often choose to build a factory for a variety。MAH system was introduced，Pharmaceutical companies can entrust enterprises with production conditions to produce，So focusing on the professional division of labor that they are good at。

 

  3. It is conducive to the implementation of the main responsibility of the enterprise

 

  In some drug damage incidents，Drug production enterprises、Business Enterprise、The responsibility of medical institutions and even R & D institutions is difficult to define，As a result, there is mutual involvement、Reconstruction of each other，The victims have not been able to solve it in fairness。MAH system was introduced，Drug listing permit holder is the responsible subject of the product，Any problem in this product，All chain links are responsible for it。

 

  4. It is conducive to avoiding risks in the research and development process

 

  There are many risks in the research and development of drugs，Even many new medicines have been clinical for the third phase，Only proved to have no exact effect，This pharmaceutical company and investors，It's very heavy。Because，Under the current registered management measures，Preliminary investment needs: Before reporting production，The entire R & D must have the corresponding drug production conditions when applying for production，The entire workshop、The equipment must be installed in place，At the same time，also requires hardware investment，Including software、Personnel、Matching of equipment, etc.。Once any wind blows before the variety is listed，Investment is to be drifted by water，These equipment will also be empty because they are not put into production in time，Wait until the next round of drug review，Equipment is likely to be updated for replacement，Re -purchased。

 

  5. It is beneficial to ensure the safety of drugs

 

  The famous song regulations issued in the plan issued by the State Council，During the use of medicine，Patients only need to have adverse reactions or adverse events，It can be used to manufacturers or holders or operating enterprises，Make claims from any party、Tips，Finally, where the quality of this product is attributable to the three parties，The legitimate rights and interests of the drug used in the holder system are the guarantee of maximizing the drug。

 

  MAH Trial Details Interpretation

 

  The trial scope of the drug listing license holder system includes Beijing、Tianjin、Hebei、Shanghai、Jiangsu、Zhejiang、Fujian、Shandong、Guangdong、10 provinces (cities)，Among them, according to the overall deployment，The Stake Sports Bettingactual introduction is Beijing and Shanghai，The system is relatively complete。

 

  Key positions

 

  The pilot solution is at the same time that there are R & D institutions and R & D personnel to apply，But considering the matching with individuals，Some key personnel settings mentioned in the comments draft，For example, quality supervisor、Key positions such as safe putting pedestrians are not reflected in the final draft of the pilot program。

 

  Application condition

 

  Beijing requires a household registration residence permit，But Shanghai only requires work address。Joint application，Beijing Requirements If many individuals apply，Be sure to recommend a person as a holder to register，There are regulations for referring to representatives。But Shanghai has no explicit regulations at present。

 

  Special medicine

 

  Beijing Regulations，Special pharmaceutical preparations must be produced by the city's enterprises，The trustee cannot be a area outside Beijing。Shanghai requires sterile supplies，The reverse preparation requirements must be commissioned in Shanghai。

 

  Obligations liability

 

  Beijing requires holders to sign a quality agreement with the trustee production enterprise，The responsibility for the quality of new drugs，and the evaluation responsibilities and recall of the after -market after refined。Shanghai requires the establishment of a quality management system covering the quality -related factors related to the follow -up production and sales，and there are some very detailed requirements，Specific requirements for the establishment of all systems。

 

  Aspect of the responsibility of the trusted production enterprise，Beijing has added the obligation to check the inspection records and archive backups of the trustee，It also stipulates that if the holder does not agree, it cannot be disposed of and sell without authorization。Supervision and management，It is required that the regulatory authorities to strengthen strict pre -listing review。

 

  Common questions

 

  1、Can the holder be two、Three houses together? Can the holders entrust multiple companies to produce?

 

  Answer: At present, in order to clarify the responsible subject，The holder can only be one，A variety can only be a holder。At present, the commissioned production measures of our country are not limited to commissioning production.，You can entrust multiple。

 

  2、It is clear that multiple applicants will jointly declare，Can I hold a text number together?

 

  Answer: The approval number can only be one person.

 

  3. Is the approval subject of the pilot work?

 

  Answer: It is currently accepted by the General Administration and the Stake Sports BettingNational Bureau is approved.

 

  4、The varieties of clinical materials and preparations that have already declared clinical materials and preparations now need to submit a raw medicine separately，Increase the supplementary application of the holder of the listing permit，Can it be accepted? Can the two dosage forms applying for a list of listing as a raw material?

 

  Answer: Yes. The policy is very flexible.

 

  5、Is it allowed to be available & quot; change to a legal holder for the qualified & quot; invisible holder?

 

  Answer: This is a very unknown country，The so -called invisible holder，Your legal holder must follow the procedure in accordance with the existing varieties and regulations。

 

  6. Can the production and packaging processes be commissioned separately?

 

  Answer: We are not allowed at present。Of course we also proposed，Actually, many of our imported packaging，The production and packaging process in many imported drugs are separated，It is not allowed to be available for our listing permit。

 

  7、Foreign R & D institutions established in China，Holding & Quot; Chinese Green Card & Quot; Can foreign researchers become applicants?

 

  Answer: The green card is not possible，But the establishment of a foreign -funded institution is possible。