Recently CFDA published three documents of The Charge of Drugs and Medical Products Registration Standard, Drugs Registration Charge Implementation Regulation (on trial) and Medical Products Registration Charge Implementation Regulation (on trial) which adjusted the drugs charging standard and formulated the medical products charging standard. It is the first time to adjust the registration charging standard in 2 decades.
The new standard formulated according to The Notice for Administrative Institution Charging Items About Republishing the Central Government Managing the Food and Drugs Supervision Department, and About Printing the Notice of MANAAGEMENT METHOD FOR DRUGS AND MEDICAL PRODUCTS REGISTRATION CHARGING STANDARD by NDRC and Ministry of Finance.
The charging for registration has the upgrading version, some of the medical products has to be charged now but before that it needn` t. No matter how high the amount of the rise, for drugs and medical products enterprise, the rising is beneficial to the clarification of the industry market and increasing the evaluation time of drugs and medical products as well.
According to the measuring principles and authorization regulated by NDRC and Ministry of Finance, CFDA employed the third-party accounting firm to calculate the cost of drugs and medical products then confirmed the new charging standard. Taking the new drugs registration as an example, the adjusted charge of domestic new drugs is £¤624,000 which is equivalent to 64% in Australia` s, 35.5% to Canada, 5.2% to US and 33.7% to Japan. We can see from the data that the registration charge surged from the original £¤35,000 to £¤624,000, the expenses discrepancy between domestic and import in generic and new drugs even closes to a half.
Industry sources pointed that it is beneficial to speed up the evaluation and assessing after rising up the registration charge, meanwhile, refusing these enterprises whom lack of market competitiveness and reducing some drugs manufacturers whom occupied the position in advance. Now we should not focus on the price rising but need to wait and see the effect, if it can help the patients and getsome good drugs in time.
Moreover, some of innovated new drugs registration application has special support, for example, some reagents for AIDS, cancer, these Chinese herb medicine or natural pharmaceutical preparations contained the effective constituent extracted from botany, animal, mineral which hasn` t been sold in domestic market, some chemical material drugs and its reagents made by semisynthetic and synthetic method which hasn` t been sold in domestic market, the type 1 biological products for preventing diseases which hasn` t been sold in domestic and abroad market, the vaccine with type 1 biological products for preventing diseases which hasn` t been sold in domestic and abroad market. It emphasized on Drugs Registration Charge Implementation Regulation (on trial) that small micro enterprise conforms to the registration application of above innovative medicine will free for new medicine registration and clinical trail supplementary application charge for innovative medicine phase ¢òor ¢ó.
It can see from the document that the charging is used for the first registration, change of registration, renew the registration application for the ¢òand ¢ó types of medical products also the ¢ó type of high risk medical products clinical trial was applied for carrying out the administrative acceptance, QMS inspection and technological evaluation. The charging is from zero paying to 150,000 registration charge for domestic the ¢ó type products, while the import products for first registration even double than domestic things.
The higher price threshold has both advantages and disadvantages for middle and small enterprises. The good thing is it emphasized on Drugs Registration Charge Implementation Regulation (on trial) that innovative medicine supplied by small micro enterprise will free of charge, but the bad thing is too high of the expenses for registration. Enterprises without the economic strength will not produce the high risk product imprudently because they can not ensure the quality. However, comparing with the huge research cost the investment for big companies is necessary. They could depend on their economic strength entering into the market and invest high riskmedical products then occupying the market in advance.
Furthermore, high charging is beneficial to clarify the market environment, reduce the severe homogenization competition, also distribute the limited supervision resources properly.
The implementation of this measure will affect the development of IVD industry. Mr. Song Haibo, Executive-Chairman and Secretary General of National Association of Health Industry and Enterprise Management Chinese Association of In-Vitro Diagnostics has his own opinion, comparing with US or other developed countries our charge is not that higher and it should be. But the question is does the reagent with the same standard and testing aim in developed countries supervise according to drugs or medical equipment? Do the developed countries do the clinical research and evaluation for the normal reagent (like GPT has been used for hundreds of years, its methodology also set up over hundreds of years)? Will the developed countries use such long time period for registration? Do the developed countries have such unclear and unscientific classification and definition? Do the IVD manufacturers and circulation enterprisesin developed countries “enjoy” these unreasonable regulations? We have to know that there is a big gap between us with developed countries no matter in research ability, materials quality or in the enterprise scale, so the Gov. needs to support positively; however, we are “enjoying” more severe and strictly constraint conditions, except the cost increasing and formalistic it does not haveany practical meanings.
IVD industry in China is still an emerging industry in developing period, because of its weakening our government should do more support, the price you lift, the better you treatment, please release more practical policies!
