Medical network August 1 - drug marketing authorisation holder system since June 2016 officially launched pilot has been more than a year, at the beginning of the pilot work effective, policy is expected to gradually appear, reflect society actively, but progress is not satisfactory. From the current situation, the provinces are in different progress. Some provinces are highly motivated and have made meaningful explorations. Some provinces have not been able to do much, not enough, and not much.
Recently, the reporter in "2017 pharmaceutical industry upgrading summit", according to drug marketing authorisation holder system pilot work was ended in November 2018, this point in time may, ahead of the timetable is now finished by the end of this year. The early termination of the pilot is mainly due to the high demand from all sectors of society, and hopes to bring this measure to other provinces as soon as possible.
At the meeting, some experts said that the pilot system should not only expand the scope but also release the dividend of the system. Entrust production should be brought into the pilot, for example, while allowing more varieties of pilot production, speed up the review of the examination and approval, simplifying approval procedures for the overall relocation, according to the capacity allocation subsidiary company of allowing varieties, accelerate the pilot work holder system.
The MAH pilot was uneven
In May 2016, the state council general office issued by the National People's Congress standing committee on authorization in some parts of the state council to carry out pilot drug marketing authorisation holder system and the decision of the relevant issues ", in Beijing, tianjin, hebei, Shanghai, jiangsu, zhejiang, fujian, shandong, guangdong, sichuan and other 10 provinces (municipalities) trial drug marketing authorisation holder system will be carried out.
From the current work, the pilot work of 10 pilot provinces and cities is uneven. In the interview, the reporter learned that the current system of licensing holders of drugs listed in the market is jiangsu, zhejiang province, fujian province, guangdong province, Shanghai and so on. Jiangsu province has taken the lead in the registration and application procedures for the registration and application of drug listed licensee, and the province has submitted 59 MAH registration applications to 30 units.
At present, fujian province has formulated the "fujian province to carry out the drug marketing authorisation holder system pilot implementation plan", a total of 10, a total of 57 species intends to apply for marketing authorization holder, and the implementation of administrative licensing examination and approval fault person, fujian province bureau leadership hosted many times the review quality analysis of examination and approval, strict access, promote the adjustment of industrial structure and the food and drug administration to supply quality improvement.
In addition, the pilot system of guangdong drug listing license holder system is also very fast, with 75 listed licensed holders of drugs and the largest number of provinces. Of the 22 registered applicants in zhejiang province, 45 varieties of registered applicants are listed as licensee; Shanghai has already had 24 pilot varieties, nine of which are "global new" class I drugs. There are 69 pilot programs for listed drug listed companies in shandong province.
In addition, the drug marketing authorisation holder system in order to speed up the pilot work of sichuan province, the provincial government issued by the implementation opinions, provincial government allocated funds for the province's top ten approved drugs for authorisation holder enterprise each varieties of 1 million ~ 2 million yuan reward. Tianjin formulated the "tianjin pharmaceutical marketing authorisation holder system pilot work plan, but by press time, has not obtained from Beijing, hebei related drug marketing authorisation holder system pilot work content.
The pilot completed two major goals
"The holder of the drug approval document is the listed licensee, so the current entrustment between drug production enterprises can be regulated according to the pilot scheme." In fact, the holder of the system is the "gap", drug regulatory reform is to carry out the whole life cycle of drugs and the whole main fulcrum of chain management, is the backbone of pharmaceutical administration law revision and the main content, has also been medicine called "gold content" high policy document.
During the meeting, leaders said, the marketing authorisation holder pilot system is to form a set of perfect, reproducible system which can be promoted, and to complete the two established goals: first, the holder of the responsibility system to ensure the quality of medicines. What are the requirements, rights and responsibilities of the listed license holders? Second, the supervision and inspection responsibility system and quality assurance system of cross-regional supervision. For example, where the holder is located, the boundary of supervision responsibility of the provincial bureau and the bureau of the trustee, and how the responsibilities of daily supervision and supervision shall be implemented.
Unfortunately, from the present work to promote, some provinces and cities have about the system, while others have but not perfect, some provinces and cities are in the study phase, should be promptly, the perfect perfect, form a complete set of system as soon as possible, for fully implementing the marketing authorisation holder system provide institutional guarantee, but also lay a foundation for revised drug administration law.
In addition, after the approval of the standing committee of the National People's Congress, the industry has a growing interest in whether medical devices carry out the system of licensing holders. Related leaders pointed out that although there is no clear medical instrument marketing authorisation holder system pilot is put forward, but the system of medical apparatus and instruments registrant with very similar, just only for current medical equipment registrant system innovation varieties, has not been pilot to all varieties of medical equipment.
On July 19, 37 central comprehensively deepen reform leading group meeting examined and approved the "about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation" has been put forward, in revision consummates the registrant system of medical equipment, the implementation of the registrant to medical equipment design, development, clinical trials, production and sales, product recalls, and adverse event reporting process, the legal responsibility of the whole life cycle, the adverse event reporting as a continuation of important review of registered and change. |
