Newly revised GMP into an important indicator of drug procurement bidding


Release time:

2013-02-06

The last boot that the industry is looking forward to has finally landed-a pharmaceutical practitioner commented on the "Notice on Accelerating the Implementation of the Newly Revised Drug Production Quality Management Regulations to Promote the Upgrading of the Pharmaceutical Industry" (hereinafter referred to as the "Notice") jointly issued by the State Food and Drug Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health in January this year. The "Notice" introduced 7 new measures, among which Article 6, which has aroused strong concern in the industry, proposes to implement preferential policies in centralized drug procurement for companies that have passed the newly revised drug GMP.

At the time when the "Notice" was released, Sun Hui, marketing director of Shaanxi Hanfeng Pharmaceutical, was planning what to do in the New Year's market. Hanfeng Pharmaceutical Co., Ltd. is an enterprise mainly engaged in the production of general medicine. Last year, it produced 30000 calcium gluconate injections, ranking first in the five northwestern provinces and regions and the top three in the country. However, the transformation of the new production line that meets the requirements of the newly revised drug GMP has increased the cost of the enterprise by 15%, the profit has been squeezed, and there is also a lack of price advantage in the bidding and procurement of various provinces (autonomous regions and municipalities). Now, the policy dividend that Sun Hui is looking forward to has finally come.

Yao Jianhong, deputy director of the Department of Medical Administration of the Ministry of Health, said: "the notice makes it clear that in the process of drug bidding, whoever first passes the newly revised GMP will have priority. The main purpose is to encourage pharmaceutical enterprises to take the lead in passing the newly revised GMP and improve the level of China's pharmaceutical industry and industrialization. There are two general principles: one is to insist on quality first and reasonable price in the process of drug bidding, procurement and use; the other is to adopt the newly revised GMP as an important indicator of drug bidding and procurement."

One-vote veto effectively improves drug quality level

Industry insiders believe that the most "fierce" point of the "Notice" is that Article 6 proposes that in the centralized procurement of essential drugs, if there are products from manufacturers that have passed the newly revised drug GMP certification participating in the bidding, other companies that have not passed the newly revised drug GMP certification The same product will no longer enter the commercial standard review stage. "the one-vote veto and completely exclusive bidding policy ensures the interests of enterprises that pass the newly revised drug GMP and resolutely exclude enterprises and products that do not meet this quality requirement from the market." Pan Guangcheng, vice president of China Chemical Pharmaceutical Industry Association, said.

"The implementation of GMP certification has greatly promoted the improvement of China's drug quality control level. The newly revised drug GMP covers the basic requirements of EU GMP, and some standards even catch up with EU GMP, which will further improve China's drug quality control level, prompt the world to re-understand the overall level of China's pharmaceutical enterprises, and promote China from a big pharmaceutical country to a strong pharmaceutical country." Pan Guangcheng said: "Industry associations actively support this policy. The state has given the policy, enterprises do not wait, do not look, early through early profit."

As a large-scale traditional Chinese medicine enterprise, in March 2012, Shenwei Pharmaceutical became the first domestic pharmaceutical enterprise to pass the newly revised GMP certification for non-final sterilization small-volume injections (including traditional Chinese medicine extraction) of traditional Chinese medicine. In December of the same year, it completed the newly revised GMP certification for all dosage forms in production. Li Zhenjiang, chairman of Shenwei Pharmaceutical, said that the newly revised drug GMP implements the concept of quality risk management and the whole process management of drug production, pays more attention to scientificity, emphasizes guidance and operability, and is conducive to improving the safety of drugs. Shenwei Pharmaceutical actively promote the implementation of the newly revised drug GMP, it is to see the bright future it is planned.

Pan Guangcheng suggested that the State Food and Drug Administration should establish a full-time, familiar with enterprise production, high professional level, and experienced newly revised drug GMP certification inspection team to improve the efficiency and quality of certification inspection; relevant departments should also study and formulate special policies to relax restrictions on enterprise product and technology transfer, and promote mergers and reorganizations. At the same time, pharmaceutical excipients and pharmaceutical packaging materials enterprises should also be included in the GMP certification system to improve the quality of drugs from all aspects.

Accelerate the shuffle to promote the optimization and upgrading of the pharmaceutical industry

At the national on-the-spot meeting on the promotion of newly revised drug production quality management standards held on December 13, 2012, Yin Li, director of the State Food and Drug Administration, said that the overall pattern of "many, small, scattered and chaotic" drug production enterprises in China has not been fundamentally changed, the production concentration is low, the ability of independent innovation is insufficient, and the level of quality management is uneven. The implementation of the newly revised drug GMP, promoting the adjustment of the pharmaceutical economic structure, and promoting industrial upgrading are conducive to the establishment of a more complete drug production and supply guarantee system, promoting the concentration of resources to advantageous enterprises, and eliminating backward productivity.

With the continuous growth of the domestic market and the continuous improvement of the overall level of the industry, my country's status as a "pharmaceutical power" has been recognized by the world, and the voice of "from a pharmaceutical power to a pharmaceutical power" is also increasing. Li Zhenjiang believes that the implementation of the newly revised drug GMP will help pharmaceutical companies seek development with an international and global strategic vision, help pharmaceutical companies actively participate in international market competition, and accelerate my country's drug production to gain international recognition and drugs to enter the international mainstream market., Improve the international status of Chinese drugs.

"Driven by a series of policies including the" Notice ", in the next two to three years, mergers and acquisitions will become the'keyword' of the pharmaceutical industry, and production capacity will accelerate the concentration of outstanding companies." Pan Guangcheng believes that the implementation of the newly revised drug GMP will further improve the industry threshold and industry concentration, and some small enterprises with insufficient capital flow and no advantageous products will have to be transformed or reorganized by excellent large enterprises. And in the leading position in the industry, with intensive, large-scale advantages of large enterprise groups will benefit.

Focus on Quality, Promote Bidding, Achieve High Quality and Price

Hanfeng Pharmaceutical passed the newly revised GMP certification for small volume injection workshop on December 25, 2011, and passed the newly revised GMP certification for oral solid preparation production workshop on January 15, 2012. Sun Hui is relaxed now, but he was not relaxed a year ago. Sun Hui said: "Due to the implementation of the newly revised GMP, our production cost increased by 15%. At that time, we could not compete with the enterprises that failed the newly revised GMP certification in the bidding in some places". At the same time, in order to meet the requirements of the newly revised GMP, enterprises often have to prepare half a year or more in advance, including personnel training, hardware transformation, technical upgrading, etc., repeated drills, self-examination and self-correction. The time cost of certification to a certain extent causes the embarrassment of the operation, light to stop production and out of stock, heavy market loss.

In fact, this is not a concern of Hanfeng Pharmaceutical. In the past two years, the industry has been arguing about the "Anhui model" in drug bidding. At the national "two sessions" in the past two years, drug bidding is "only low price is taken" or "high quality and good price", which has become a "hot word" among representatives and committee members of the medical and health sector ".

The "Notice" on the adoption of the newly revised drug GMP enterprises in the tender to give policy tilt. Pan Guangcheng pointed out that this means that the first enterprises to pass the new certification will have a greater advantage in the centralized bidding and procurement in the next two to three years, which also guides the direction for the improvement of China's drug bidding and procurement policy.

Li Zhenjiang suggested that we should take advantage of the "notice" to further improve the "double envelope system" for the bidding and procurement of essential drugs, raise the threshold of technical standards, and integrate the two factors of quality and price, so as to truly reflect "quality first and reasonable price", avoid malicious price competition, and make the production of essential drugs really tilt to superior enterprises, so as to improve the quality of essential drug products and ensure supply, realize the large-scale and intensive production of basic drugs to ensure the quality of drugs and the safety of drug use by the public.

After editing:

This newspaper's interpretation of the "Notice on Accelerating the Implementation of the Newly Revised Drug Production Quality Management Regulations and Promoting the Upgrading of the Pharmaceutical Industry" by the four departments has come to an end in this period. At present, all localities and relevant departments are actively promoting the newly revised drug GMP certification, and industry associations and other organizations have also used their own advantages to promote the implementation of GMP. A series of encouraging policies and measures have been implemented, creating a favorable environment for enterprise transformation and upgrading from all aspects. At the end of this year, sterile drug manufacturers such as injections must pass the newly revised GMP certification, and other types of drug manufacturers must also pass the certification by the end of 2016. Time does not wait. The majority of pharmaceutical manufacturers should increase their confidence, accelerate their pace, make good use of the encouragement policies given by the state, actively implement upgrades, and participate in and witness the process of my country from a major pharmaceutical country to a pharmaceutical power with practical actions.