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  1. Drug marketing authorisation holder system: what is not open around the threshold

    Medical network - January 21 Let public license and production license of separation, developers do not have to invest can make the research and development into a pharmaceutical products, but these are not simple in expert opinion --


    "Actual producer, can guarantee the quality of the drugs? Dealer in the process of transportation, storage, whether accord with the requirement of pharmaceutical properties?" Recently, the Beijing municipal food and drug administration drug registrar of Hu Meifang told science and technology journal reporter in an interview, "drug marketing authorisation holder (MAH) system, not the outside world as simple".


    MAH system, is common in today's international society shall practise a system of drug management. In addition to pharmaceutical enterprises, the system also allows the drug research and development institutions and researchers obtained drug approval number, phase separation with production enterprises. As a result, developers can not only reduce production conditions facilities, but also get more in return. On 14 January, the Beijing municipal food and drug administration to the public, drug marketing authorisation holder system pilot work start.


    But in Hu Meifang point of view, "MAH system, in China is faced with many challenges. How is the lifecycle of drug safety, efficacy and quality controllable accountable to the public, as Beijing first try is not open around the threshold".


    Of producers in where?


    "Because of the marketing authorization and the production license bundled together, for the research results into usable medical products, research and development or investment, cost of expanding, cannot afford to engage in other new drugs research." Pfizer China corporate affairs director danlong feng presented made a analysis of the "production enterprise in the pursuit of market efficiency, expanding agent varieties and to build new production lines, pharmaceutical production caused by repeated construction and high rates of production equipment idle false" boom "phenomenon, and government regulators have waste a lot of time on repeated examination and approval."


    As a CPPCC member, she was on the national annual, build system of pharmaceutical marketing authorisation holder. However, she also stressed, build system of marketing authorisation holder, not directly copy the practice of Europe and the United States, and should take into account the reality of our national conditions and the system feasibility.


    This "feasibility problem", Hu Meifang expressed as "challenge".


    "In addition to pharmaceutical companies, drug research and development institutions and researchers can also apply for and obtain a drug approval number. But the question comes, how to find qualified producers? Strength of the drug companies: why do you want to OEM for you? Can you manufacture of weaker?" Hu Meifang said.


    On November 4, 2015, the 12th session of the 17th session of the standing committee of the National People's Congress by authorization of the state council in Beijing, tianjin, hebei and other 10 provinces, municipalities directly under the central government to carry out the pilot drug marketing authorisation holder system. The pilot period is 3 years.


    Hu Meifang for Beijing's first try, and said, "how to sign a contract with the actual producer? How to monitor the producer's production behavior? How to perform the duties of a given product safety and quality? This requires drug marketing authorisation holder locked well. Because once appear problem, holder should take full responsibility for drug quality and safety."


    How to find qualified dealers?


    "A man can do so much? Research and development institutions, scientific research personnel can't all understand, this would require the distributor to help us. But the dealer in the transport, storage, whether work in strict accordance with the drug properties, how do we regulate?" An anonymity said the researchers.


    How to find qualified dealers? This is the very concern Hu Meifang second question. "Personal do holders, the feasibility of the present basic does not have the actual operation, and rarely in the world. Because of the ability and responsibility is to draw the equal sign. So, people don't blind to enter. Look for, supervision of qualified distributors, this is holders have to face the challenge of".


    "Different drugs for conditions, such as temperature, humidity, with differentiation requirements. Dealers how to safeguard, may affect the quality and efficacy of the drug. Drug marketing authorisation holder, should how to regulate the dealer?" Hu Meifang said. "this needs to be agreed in the contract both sides, the holder will also need to get ready for your".


    For the holder's own preparation, Hu Meifang think, first of all, to study national pharmaceutical trading enterprise qualification and distribution policy, regulation, determine their distribution pattern; Second, facilities for conditions, dealer management level can meet the demand of their products.


    "How to perform the duties of drug safety monitoring? How to perform the duties of the continued research to drug safety? How to fulfill the pharmaceutical supervisory and administrative laws and regulations stipulated by the relevant responsibilities?" Hu Meifang said, these are MAH system is not open around the threshold.


    Who will help dissolve the risk of liability?


    "The marketing authorisation holder responsibility is very large. So, who will help dissolve the liability risk?" A from government regulators said, "at present, our country also lacks such commercial insurance".


    To introduce and establish the marketing authorisation holder system, danlong feng presented made believe that three supporting system must be established.


    "First, build system of adverse drug reaction relief fund, drug approval number holder shall pay the drug risk funds, and raising funds through various channels, providing necessary relief to victims of adverse drug reactions; second, to explore a mandatory drug harm commercial insurance system, drug approval number holder must be forced to buy commercial insurance, strengthen the ability of its liability; third, the implementation of the 'civil compensation first, then administrative forfeiture of special civil system, build system of punitive damages at the same time, to better safeguard the rights and interests of victims." Danlong feng presented made said.


    "At present, the United States and other countries have relatively complete commercial insurance. But in our country, in view of the drug marketing authorisation holder system, everything just starts. How to perform due to defects listed drug damage liability to pay compensation to consumers? How to buy commercial insurance? How to buy share? How to look for some financial institutions to give guarantees? A responsibility, how do you determine the compensation amount of? These are all we are faced with the new task." Hu Meifang said.


    "Build system of pharmaceutical marketing authorisation holder, it is an important and key steps of drug regulatory system, is also a breakthrough of the reform of drug regulatory system in our country. The new system can to a certain extent, ease the current 'bundled' problems in the management mode, stimulate the enthusiasm of r&d staff, restrain low level repeated construction, from the source to promote the pharmaceutical industry upgrading." Hu Meifang said, "this is a new reform, we have to face difficulties, and decided to solve the problem."