Discussion on the Green Concept of Drug Supervision


Release time:

2019-02-18

Drugs are special products related to people's health and life safety, and ensuring the safety and effectiveness of drugs is an important goal of drug supervision. At the same time, pharmaceutical products in its production, operation and use process, may bring pollution to the environment.

To achieve the development goals of the 13th five-year Plan period, we must firmly establish and earnestly implement the development concept of innovation, coordination, green, openness and sharing. Drug supervision should also establish the concept of green development, and on the basis of ensuring the safety and effectiveness of drugs, minimize pollution and protect the environment.

The author believes that drug regulatory authorities can guide people to establish the concept of green development in drug registration, quality standard formulation and regulatory regulations.

In the process of drug registration review, the review of dosage forms, prescriptions, processes, and specifications should take into account the safety, effectiveness, ease of use, and environmental protection of drugs; on the basis of benefit and risk assessment, it should also respond to drugs Comprehensive assessment of benefits and pollution.

Such as traditional Chinese medicine preparations, try to use traditional dosage forms, not only can reduce the energy consumption of extraction and concentration process, but also reduce the environmental pollution caused by the production of solvent, because the production of commonly used solvent ethanol, will produce a large number of high concentration, high temperature, high suspended solids wastewater. Another example is that some pharmaceutical manufacturers declare small dose specifications that have nothing to do with the dosage, or divide the packaging specifications of a course of treatment and a package into several small packaging specifications, which actually do not bring convenience to medication, but increase the number of packaging materials and the use of paper.

The formulation of drug quality standards should not only consider ensuring the safety and effectiveness of drugs, but also consider saving resources and protecting the environment. Fortunately, in the preface of the 2010 edition of the Chinese Pharmacopoeia, the State Pharmacopoeia Commission wrote for the first time that "this edition of the Pharmacopoeia also actively advocates green standards, and strives to adopt less toxic, less polluting, conducive to saving resources, protecting the environment, simple and practical detection methods"; the guiding ideology of the 2015 edition of the Chinese Pharmacopoeia is written into "learn from advanced experience at home and abroad, protect the environment and save resources, continuously optimize, improve and improve the national drug standards"; the outline of the 2020 edition of the Chinese Pharmacopoeia will "firmly establish the five development concepts of'innovation, coordination, green, openness, and sharing'" into the guiding ideology and overall goals. The concept of green environmental protection has been put forward in three consecutive editions of the Chinese Pharmacopoeia. Therefore, the author also hopes that the State Pharmacopoeia Commission will consider treating the product quality standards produced by normal processes differently from those produced by abnormal processes, drawing on the practice of supplementary inspection methods for drugs, incorporating the inspection items used to fight against counterfeit and inferior products into the product quality standards produced by abnormal processes, and reducing the inspection items produced by normal processes.

In addition, the outline of the 2020 edition of the Chinese Pharmacopoeia proposes that "we should be problem-oriented, closely combine the formulation and revision of drug standards with drug consistency evaluation, safety evaluation of traditional Chinese medicine injections, drug quality evaluation sampling, adverse drug reaction monitoring, drug re-registration and other work, so as to form positive interaction, information sharing, coordinated promotion, and promote the improvement of supervision ability, the author suggests that the few unqualified items should be included in the selection and inspection items, and the enterprises should select and inspect according to the actual situation. This not only does not violate the requirements of GMP, but also reduces the inspection items under the premise of risk control, thus saving resources and reducing pollution.

The compilation outline of the 2020 edition of the Chinese Pharmacopoeia also vigorously promotes the diversification of the publishing forms of the Pharmacopoeia, and proposes to promote the digitization and electronization of the Pharmacopoeia, which can not only meet the needs of different customer groups, but also save a lot of paper and ink.

The revision and improvement of regulatory laws and regulations and the process of supervision should also establish five development concepts and pay attention to resource conservation. For example, the risks of raw materials and pharmaceutical packaging materials purchased by pharmaceutical manufacturers mainly come from storage and transportation links. Therefore, the manufacturers should be given the independent decision on inspection items and inspection batches according to the results of risk assessment, so as to reduce the whole project inspection which is of little significance to risk control. The chemical raw materials that exceed the validity period should also be disposed of scientifically and reasonably. Article 49 of the "Drug Administration Law" emphasizes that the production and sale of inferior drugs are prohibited, and drugs that exceed the validity period shall be punished as inferior drugs; Article 100 clearly states that chemical raw materials are included in the category of drugs. However, chemical raw materials are not preparations, do not specify the usage and dosage, and are not directly used in clinical practice, which does not meet the definition of drugs in the strict sense. Therefore, it is suggested that the enterprise should be given the right to rework the chemical raw materials that exceed the validity period.

Although the API rework section of the GMP Guide allows this situation to be reworked, in practice, regulators rarely follow the GMP Guide to deal with it. After inspection and evaluation, it can be treated as rework products to avoid waste of resources and reduce environmental pollution. In addition, when formulating a drug sampling plan, big data analysis should be used as much as possible, and then a targeted sampling plan should be formulated. In addition to the evaluation of the sampling inspection to the whole project inspection, other supervision sampling inspection only test targeted projects can be.

It is China's basic national policy to persist in saving resources and protecting the environment, and the defense of blue sky, clear water and pure land is continuing to advance. Environmental protection has a long way to go, and it is necessary to take care of nature and use it in a measured way. Drugs are used to prevent, treat, and diagnose human diseases. The production and use of drugs should not pollute the environment and bring more and more complex diseases to humans.