End of GMP: is there any play in technology transfer?

Source: pharmaceutical economic news 2016-01-05 is a key time point for GMP certification in 2015-2016 On December 30, 2015, CFDA issued a notice to transfer GMP certification to the Provincial Bureau From January 1, 2016, the food and Drug Administration of each province, autonomous region and municipality directly under the central government shall be responsible for the GMP certification According to the requirements of GMP (2010 Revision), drug manufacturers (workshops) that failed to meet the requirements before December 31, 2015 cannot continue to produce drugs after January 1, 2016 In order to promote the upgrading of the pharmaceutical industry, CFDA issued the notice of the State Food and Drug Administration on matters related to the transfer of pharmaceutical technology in the process of implementing the newly revised pharmaceutical production quality management specifications, which states that "pharmaceutical manufacturers who give up the production and transformation of the whole plant or some dosage forms can transfer the production technology of corresponding varieties to those who have passed the newly revised GMP Certified enterprises, but the production technology of all varieties of the same dosage form is limited to one-time transfer to a drug manufacturer " The closing time of such technology transfer is December 31, 2016 Does this mean that GMP certified enterprises can start harvesting in 2016? [analysis] three reasons for "no play" are that the passing rate of 1gmp is on the high side Take Guangdong as an example, the data of Guangdong food and Drug Administration shows that there are 83 and 81 enterprises in production of injection drugs in Guangdong Enterprises obtained new GMP certificates, with a passing rate of 97.6% Nine sterile API manufacturers are in production, and all of them have obtained the newly revised GMP certificate There are 496 enterprises in production of general preparations, and 356 enterprises have obtained the newly revised GMP certificate, with a passing rate of 72% The high passing rate of GMP means that most enterprises are more willing to choose GMP upgrading, and the transaction heat of variety production technology transfer is relatively low Enterprises that fail to obtain the 2010 GMP certification on time mean that they will be shut down, but the manufacturers can still continue certification after the deadline The production of blood products, vaccines, injections and other sterile drugs of pharmaceutical manufacturers should meet the GMP requirements of 2010 version by December 31, 2013 However, of the 81 injection drugs in Guangdong that have obtained the newly revised GMP certificate, 31 were only approved in 2014, and 2 were only approved in 2015 Since 2016, GMP certification has been transferred to the Provincial Bureau, and the National Bureau will supervise more by means of flight inspection and spot check Due to local protection, it is expected that the passing rate of GMP will remain high, and the impetus for manufacturers to integrate through GMP upgrading will be even less For individual pharmaceutical manufacturers who give up the whole plant or part of the pharmaceutical form production and transformation, it is more likely to complete regional M & a rather than cross provincial integration in the province 2 High value projects have long been concentrated in the hands of listed enterprises, large state-owned enterprises and foreign enterprises The main target of M & A is chemical oral medicine, followed by external medicine From the perspective of bidding policy, the provincial sales volume that can enter the hospital market in the future will be more than 5 million yuan In 2014, there were 196 generic names with sales of more than 50 million yuan in the market of key sample hospitals The manufacturers corresponding to these generic names are mainly listed enterprises or companies that have changed the shareholding system, large state-owned enterprises and foreign enterprises There is basically no problem for these enterprises to pass the 2010 version of GMP certification It can be said that there is no possibility of M & A in 2016 For example, in 2014, clopidogrel ranked first in the market of key sample hospitals, with 3 manufacturers, including 1 foreign enterprise and 2 domestic listed enterprises In fact, capital driven M & A took place earlier In November 2014, Lepu medical arranged to acquire Henan xinshuaike without clopidogrel No matter which of the 196 BCS products need to do bioequivalence clinical trials, but from the perspective of the manufacturer background, these enterprises do bioequivalence trials with no less money, have more advantages in competing for clinical resources and more standardized cro organizations to cope with increasingly strict clinical self-examination, and are likely to complete the first three consistency trials At present, there are more M & A projects in the market, including 1-5 specifications of oral Chinese medicine and more than 10 manufacturers of general chemical medicine This kind of product has not been sold in the hospital market, and it is expected to be clinically necessary to enter the provincial procurement catalogue in the future; or it is the product with low price or poor price maintenance After the approval of technology transfer of this kind of chemical medicine, if it can not guarantee the uniform supply in the market, whether it is worth additional investment and consistency test needs to be reevaluated Very few projects that have not yet been merged by listed enterprises, large state-owned enterprises and foreign enterprises generally go through the customers in the merger and acquisition market The project leaders of listed enterprises and large state-owned enterprises have searched for prices for many times, and the prices have been basically talked about for several rounds The psychology of the seller has been pushed to the high position of the market, and this category is more about whether there is a price or not 3 The system of drug marketing license holder diverts part of technology transfer projects The system of drug marketing license holder refers to a system in which the holder of drug approval number, including drug manufacturing enterprises, research and development institutions and scientific researchers, pushes drugs to the market in their own name and bears corresponding responsibilities for the whole life cycle of drugs Before, only drug manufacturers could apply for drug registration and obtain drug approval number At present, the pilot system of drug listing license holders has been carried out in 10 provinces and municipalities directly under the central government in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, allowing the separation of drug listing license holders and production enterprises, which means that the production enterprises with perfect qualifications in the above provinces may not only obtain production approval through technology transfer The drug marketing license holder system will divert some new drugs approved for marketing, generic drugs approved according to new standards, and technology transfer projects of drugs that pass the consistency evaluation of quality and efficacy [prospect] the three fortresses "Youxi" 1 international project is favored It is expected that more and more powerful enterprises will choose to merge and acquire foreign high-quality enterprises or obtain high-quality product agency rights of foreign enterprises to introduce products into China Moreover, the price of foreign projects is not so high relative to the valuation, which is more valuable for investment If the acquired enterprise itself has the GMP qualification of the United States or the European Union, the domestic enterprise can enter the European and American generic pharmaceutical market without spending a lot of money to upgrade the European and American version of GMP waiting for verification The risks of such projects are mainly the RMB exchange rate, the state's control policies on capital outflow, and the time when the projects are listed in China 2 The cases of strong alliance or asset replacement will increase The medical insurance fee control and clinical self-examination will be strict The industry will become more and more standardized, which will force enterprises to form a group or integrate Holding a group for winter may not be able to really warm up, but scale can bring price competitive advantage It is expected that large-scale enterprises, listed enterprises and foreign enterprises may cooperate and integrate resources in various modes to maximize the interests of all parties, such as foreign enterprises will hand over the production and sales of products that have expired the original research and many domestic listed enterprises to large-scale state-owned enterprises or listed enterprises In the future, pharmaceutical enterprises will pay more and more attention to vertical specialization and concentrate on subdivision rather than diversified layout, so as to obtain the maximum marginal profit Therefore, it will be a trend to sell the products in the treatment field that they are not good at and purchase the products that can supplement their advantages in the treatment field If the negotiation is successful, such projects are likely to be large projects for multiple enterprises to trade mutual assets at the same time The second quarter of 2016 is the final harvest period of "leakage detection" As the transfer of drug technology requires the transferee to complete the stability test before supplementary application can be made, it means that the end of the first quarter of 2016 and the beginning of the second quarter are the deadline for the buyer to sell and the seller to ship At present, there is no relatively fair transaction price for pharmaceutical market projects as a whole It is predicted that at that time, the transaction price will be very chaotic If the price is too high, there will be no transaction volume If the price is too low, the prospect will be too poor, there will be no M & a value, no buyer wants The provincial local protection policies increase the difficulty of M & A, and the provincial bureaus prefer to keep the product approval documents in the provinces so as to support the M & A projects in the province, rather than the M & a offer projects launched by cross provincial enterprises to their own enterprises in the province In the end, products without buyer's acceptance and ready to give up GMP upgrading will not be registered again, and manufacturers and products will be eliminated at the same time To sum up, it is difficult to "pick up" good projects in 2016 without passing GMP projects It is expected that most of the technology transfer projects in 2016 will be completed in the province In the long run, domestic pharmaceutical M & A projects are mainly listed companies and large enterprises that have completed the share restructuring but not listed companies Listed companies, large enterprises and their funds participate in equity trading projects, that is, they have completed share restructuring but not listed enterprises In the future, the projects that complete capital withdrawal through the new third board, IPO or M & A will also be small and active The low return rate of such projects further leads to low trading volume.