2017 China pharmaceutical industry economic operation index released!

Source: Medical Economic News December 12, 2017 medical network CFDA recently released the management measures for joint review and approval of APIs, pharmaceutical excipients and drug packaging materials and pharmaceutical preparations (Draft for comments) (hereinafter referred to as the draft for comments), which further clarified the system of no separate review and approval of the original and auxiliary packages Deepening the reform of drug registration: prior to that, the competent department had made a decision to implement the filing system or related review and approval instead of the registration management for pharmaceutical excipients and drug packaging materials In this opinion draft, the management of pharmaceutical excipients and drug packaging materials was adjusted again and the API was included in the scope of reform The reasons include: the legal system of drug registration is not perfect enough, the API and drug packaging materials are the registered management items stipulated in the drug administration law, and the pharmaceutical auxiliary materials are the items listed in the administrative examination and approval reserved by the State Council, so the original auxiliary packaging management mode needs to be changed, and the corresponding legal provisions need to be modified or effectively authorized At the same time, the original auxiliary package is not reviewed and approved separately, but also involves changes in the internal and upper and lower management functions and responsibilities of the food and drug regulatory system, as well as the adjustment of the legal relationship between the drug preparation producers and the original auxiliary package production operators   According to the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices issued by the two offices, all relevant departments in all regions should adhere to the rule of law thinking and the rule of law way to promote the reform, and constantly improve the relevant laws, regulations and system system If the reform measures involve the modification of laws or need to obtain corresponding authorization, the law should be modified according to the procedures or authorized by the legislature Implementation The opinions of the "two offices" have further clarified the legal requirements of drug and medical equipment review and approval reform For example, the Drug Administration Law lists the use of unapproved APIs to produce preparations as fake drugs, the use of unapproved pharmaceutical packaging materials to produce drugs as inferior drugs, and whether the API and pharmaceutical excipients manufacturing enterprises still implement the drug production license management, etc all need to modify the relevant provisions of the drug administration law or make clear Put forward new requirements for interested parties "opinion draft" put forward new requirements for original auxiliary package manufacturers and drug marketing license holders If the original auxiliary package is not reviewed and approved separately, it does not mean that it is not reviewed and approved, but the "one batch system" of the original auxiliary package before the first change is "one by one review and approval system" Through the joint review and approval, the original auxiliary package will be contacted with the specific drug registration applicant and variety for review and approval, and the approval number or registration certificate of the original auxiliary package manufacturer will not be issued Even for the same product, due to the different process or process parameters of the registration applicant, the joint review and approval procedure may be triggered, and the record data of the original auxiliary package manufacturer may be the direct factor affecting the success of registration Promote the diversification of quality standards of the original auxiliary package For example, it is proposed in the opinion draft that for the same excipients with different quality control requirements such as density, crystal type, particle size and viscosity, as well as for the premixed excipients used in oral solid preparations such as coating excipients, the APIs with different quality control requirements such as crystal type and particle size will be classified and numbered according to the varieties and specifications under the same registration number, and the registration number will be different, which is beneficial to According to this, drug marketing license holders study and form product characteristics According to this trend, the original auxiliary package manufacturing enterprises that have been approved to use in the listed preparations before the implementation of the opinion draft shall still go to register It can be foreseen that API database, pharmaceutical excipients database and drug packaging materials database are very rich in content How to select the original and auxiliary packages requires the reserve of professional knowledge To clarify the legal relationship between the original manufacturer of auxiliary package and the holder of drug listing license In the sales contract between the original manufacturer of auxiliary package and the holder of drug listing license, the specific obligation of notification becomes mandatory That is to say, if the holder of drug listing license finds that the preparation has quality problems related to the original auxiliary package, he shall inform the original enterprise of auxiliary package in time If the original auxiliary contracting enterprise finds that there are quality problems with the products, it shall inform the holder of the drug listing license in a timely manner To understand the quality of the original auxiliary package, we must break through the convention that "quality standard" becomes the only quality agreement, and transform it into notification and risk management centered on "quality problem" In order to minimize the risk, it is necessary to inform the other party about the quality problems as much as possible The more information you tell the other party, the smaller your risk and the greater the responsibility of the other party The draft also sets up a double reporting mechanism, that is, the drug listing license holders and the original auxiliary contracting enterprises should take corresponding measures to deal with the problems, if necessary, they should recall the listed preparations and report to the provincial food and drug regulatory authorities If the original auxiliary contracting enterprise finds that the holder of the drug listing license commits fraud, etc., it shall report to the provincial food and drug administration The first is to establish the credit files of the original auxiliary contracting enterprises based on the registration and review and approval information, and to make public the inspection and sampling of the original auxiliary contracting enterprises The second is to normalize the supervision of the original auxiliary contracting enterprises, including daily inspection of the original auxiliary contracting enterprises, or on-site inspection of the original auxiliary contracting enterprises according to the problems found in the supervision and inspection of drug listing license holders In case of any quality problem of the preparation, the holder of the drug listing license shall be investigated for responsibility according to law In case of any illegal act of the original auxiliary contract enterprise, it shall be dealt with according to law In case of drug quality problems caused by illegal use of the original auxiliary package, the holder of the drug listing license shall bear all responsibilities If there is any authenticity problem in the registration data of the original supplementary package, the food and drug administration shall terminate the review and approval of the preparation and the original supplementary package used, and terminate the use of the original supplementary package in the listed preparation If there is any illegal act, it shall be dealt with according to law "Opinion draft" embodies the rule principle of fault liability, that is, the punished person must have illegal behavior, or expressed as the subjective existence of intentional or objective existence of fault What needs to be further clarified is that there may be some special circumstances in the original auxiliary package used by drug marketing license holders, and how to achieve joint review and approval needs to be further clarified When implementing registration management for APIs, some APIs may not have approval numbers, and there are less than 1800 APIs with approval numbers The actual number of APIs used in the production of preparations is more than that Some APIs with approval numbers are not necessarily produced by those with approval numbers For example, in the case of phenol which was punished by the anti monopoly law in the early years, if the producer set up a GMP workshop for the production of phenol, the price is not high according to the cost accounting There is no difference between the content of medicinal phenol and the content of analytical pure phenol, but the price of medicinal phenol is much higher than that of analytical pure phenol The reason for the high price of medicinal phenol lies in the market monopoly formed by the advantage of approval number Another possibility is to purchase analytical pure phenol for repacking Similar situation also exists in the industry of auxiliary materials and drug packaging materials For example, inorganic acid, inorganic salt, inorganic alkali, etc can only be produced by large-scale chemical enterprises, most of the auxiliary materials enterprises that originally held the approval number may be sub packaged, and most of the materials purchased by the drug packaging material production enterprises are processed by molding, printing, etc., so it is less likely to change the internal quality Whether the drug marketing license holder is directly responsible for the quality or not is a choice, which needs to be further explored in the implementation of the system.