Medical network on July 19 - five years ago, the state council on the food drug administration system of "armed" provisions in put forward: "drug production administrative licensing will be gradually integrated into and drug production quality management standard certification an administrative license". Some speculation at that time: the flag of GMP will also be able to play how long? In mid-march, the relevant state departments clear stop GMP certification fees, the industry has a lot of rumors GMP certification may be cancelled.
GMP certification will be cancelled? The author thinks that, even if no longer have permission to the nature of the certification activity, but GMP inspection absolutely not be canceled. The author lists eight reasons, the relevant departments for reference.
Reason a disaster created by drugs
In 1957, Sally amine (thalidomide) on the market in Germany, then appeared in 28 countries such as Britain, Sweden, Switzerland market. Indications for the drug during pregnancy. Due to the lack of rigorous pre-market pharmacological experiments, severe teratogenic reaction in the reaction stopped selling for 6 years, people in large areas of "the seal leg" or fetal death.
The FDA has not approved pharmacological experimental data lack of thalidomide to enter the United States, avoiding the more pregnant women are violated, but for the warning role in the drug administration of the United States. The U.S. congress to the federal food, drug and cosmetics act has made a major revisions to passed the Krakow, wo - Harris amendment. This "amendment" authorized the FDA to comprehensively strengthen for all drugs listed in front of the production and sales management, and fully implement the "drug production quality management standard". In 1963, the FDA released "drug production quality management standard".
Reason 2 WHO issued "international standard"
In 1967, during the period of the 20th world health assembly, the WHO to draft the GMP. In 1969, the world health organization (WHO) published "drug-production quality specifications", (WHO) TRS418.1969). In 1992, the WHO to revise "drug production quality management norms", released at the same time the biological products production quality management standard. In 1997, the WHO will be the pharmaceutical production quality management norms "as the second version of the supplementary provisions of the international pharmacopoeia published. In 2002, the WHO released the sterile drug production quality management norms ". In 2009, the WHO released the revised GMP2009 version.
Reason three pioneers to study
No doubt, in the GMP provision into a lot of scientific management ideas and modern management means, some developed countries has already begun before in our country. We are the pioneers in the study. In addition to the FDA, many western developed countries, such as Britain, Italy, Austria, Switzerland, Sweden, Denmark, Norway, Iceland, Finland, formulate and implement in the 1970 s and the GMP suited to its national conditions, from raw materials into finished products, from hardware to software, is fairly strict standards are put forward.
As a forerunner of the eu's European economic community as early as 1972 issued the first GMP, used to guide its members of pharmaceutical production. Japan in 1973 formulated the GMP, and formulated the detailed rules for the implementation in 1980. In Taiwan's domestic GMP regulations issued in 1982, five years to reach standard, production enterprise must shut down. Japan and South Korea and other countries and our country Taiwan area in the process of implementing GMP, not only to the chemical pharmaceutical production enterprise, the traditional Chinese medicine (Chinese medicine) also puts forward the specification requirements.
The premise of reason four drugs to enter the international market
The WHO's "drug quality certification system in international trade" specific provision: export pharmaceutical producing enterprises must provide relevant production and monitoring conditions, production system according to GMP regulations. Can not meet the requirements of GMP, the drug will not be able to enter the international market, it has become the consensus of most countries. Production of drugs in our country for a long time not in the national market "appearance", and we implement GMP is relatively slow. Until today, many of our apis can "go out", in the form of intermediate preparations in the foreign market is more difficult to find. The good news is that, in recent years, with the strength of the our country GMP, there have been more and more enterprises, species survived the FDA, the European Union related certification, more and more drugs (including active pharmaceutical ingredients) to move towards the world.
Reason to quest in five hundred and twenty
China's implementation of GMP, experienced more than 20 years of difficult exploration, has experienced several degrees of drug regulatory system also changes. With reference to some countries in 1982, the Chinese medicine industry company of GMP, formulated the "drug production management norms", in some enterprises on a trial basis. In 1984, the original state drug administration issued by the "drug production quality management norms", in the pharmaceutical industry. On this basis, on March 17, 1988, the original GMP issued by the ministry of health, and in 1992 issued a "revision". In 1995, the ministry of health issued "notice about drug certification work. In the former ministry of health and the state department of pharmaceutical administration, by the end of 1998, the national GMP certification of enterprise (workshop) 87, mainly is the joint venture.
In 1998, the original national drug administration organization the revision of the GMP. On June 18, 1999, in order to bureau to 9, issued "drug production quality management standard (revised in 1998). On August 24, 1999, on the implementation of the "drug production quality management norms" to the relevant provisions of the notice (its GuanAn [1999] no. 261). Notice is put forward: "the varieties step-by-step divide dosage forms and organize the implementation of GMP certification. This decision: powder injection (including producing injection), large capacity injection, and genetic engineering products should comply with the requirements of the GMP by the end of 2000, through the GMP certification; small capacity injection production should be in line with the GMP requirements, by the end of 2002 through the GMP certification. The implementation of GMP certification work will be combined with the renewal work" drug-production enterprise licence ", within the prescribed period of time, has not obtained the pharmaceutical GMP certificate of the enterprise, will not be replacement."
At this point, began to accelerate the process of our implementation of GMP. By the end of 2000, a total of 713 enterprises through certification, at the end of 2001, there were 1001 through certification, at the end of 2002 there are 1470 enterprises through the 1998 version of the GMP certification. Twenty years exploration, finally gradually in line with international standards.
Reason six into the orbit of legal system
Twenty years of travel, GMP still failed to the Promised Land. Despite the related department to do some advance work, but after all, the lack of mandatory binding. A landmark in the history of our pharmaceutical production quality supervision, was revised in 2001 promulgated by the pharmaceutical administration law enforcement. Article 9 of the specific provision: "drug production enterprise shall, in accordance with the pharmaceutical supervisory and administrative department under the state council shall, in accordance with this law, formulate the" drug production quality management norms "production organization. Pharmaceutical supervisory and administrative departments in accordance with the regulations on pharmaceutical production enterprise is in line with the requirements of the" drug production quality management norms "certification; to qualified certification, certification certificate shall be issued."
Shots in the hand, forced to advance. After a short transition period, October 23, 2003, the state food and drug administration issued a "about comprehensive supervision and implementation of pharmaceutical GMP certification related issues notice" : "before June 30, 2004, all medicine preparation and API manufacturing in our country must comply with GMP requirements. Since July 1, 2004, who has not obtained the corresponding dosage forms or categories of the pharmaceutical GMP certificate for medicine preparation and API manufacturing enterprises (or workshop), shall stop the production." In the first round of GMP certification in accordance with the comprehensive end at the end of 2004. Despite the GMP certification of the quality differences between regions, but compared with the previous, pharmaceutical production quality supervision in our country have a big leap forward, who also can't deny it.
The provisions of the law can be improved, but the key is not constantly changing, such as GMP, in accordance with the law enforcement problems.
Reason seven continues to ascend
As a mandatory requirement, GMP implementation in our country has been more than three cycle (each certification period of 5 years). In the meantime, GMP standard is not static. 1998 version, the pharmaceutical administration law have not revised, GMP is still in the stage of "soft" and related terms and conditions are relatively big gap between the international standard.
Since the implementation of GMP became the statutory obligation of the pharmaceutical production enterprise, the specific content of the state GMP for uninterrupted complement and perfection, the supplement and constantly admixture in the evaluation system of certification. Constantly in the process of perfecting the standard, and the United States, the European Union, the latest version of the GMP such as Britain, Japan, and people with technical requirements for drug registration international coordination meeting (ICH) "API GMP standard, finally unveiled in March 2011, and fully integrate into the international Chinese GMP2010 edition.
The commonly known as "the new GMP, countries also adopted a" push "in accordance with the law enforcement measures. A new version of GMP compared with the original standards rise a few steps, will be the latest international management idea runs through my emotions, and will be December 31, 2015, as to "close the back door" point of the new GMP requirements. After this point, if you haven't passed the new certification, lost to continue production related drugs. So, for drug firms are vigorous to the implementation of the new version of GMP, accept the round after round of certification examination, standardize the production of most corporations increasingly improved.
The CFDA has been research GMP path of ascension. Along with the 2010 release of sterile drugs, pharmaceuticals, biological products, blood products, such as Chinese native medicine preparation 5 appendix. As of March 13, 2017 promulgated "biochemical drugs appendix", is the 12th in the appendix. Previously issued radioactive drugs, Chinese medicine yinpian, medical oxygen, sampling, computer system, qualification and validation etc six appendices. The appendix is the improving of the 2010 edition of GMP, its requirements is to make Chinese pharmaceutical fully to the orbit of the world, these in the continuous extension of the orbital shortening the distance between us and the world.
Reason in eight is better than the GMP management approach?
In the 21st century is the century of quality. Attaches great importance to the quality and development quality, improve the quality is an eternal theme in the process of enterprise development. China is no longer a closed country, we have already on the way to fully open striding forward, this momentum who can't stop!
GMP has become an international pharmaceutical trade general requirements for pharmaceutical production quality, to become an international generic drug production quality management must follow the rules. Through the practice of more than half a century, has experienced numerous large and small phytotoxicity events, governments around the world, management institutions, experts and scholars, including pharmaceutical companies, the industry, the cognition of GMP has converged: to have consistent implementation of GMP standards, strict implementation of certification examination system, will be able to maximize the lower due to the production of non-standard drug risk, and you can also greatly reduce the cost of drug manufacturing and trade. The future expected goal is: through the GMP certification almost the same, the same specifications of drugs can be popular all over the world.
Just think, today, there are better than the GMP management measures? (the author: nantong in jiangsu province food and drug supervision bureau) |
