New "Drug Administration Law" Released Experts Call for Correct Interpretation

"A movie changed China's Drug Administration Law" "illegal purchase of drugs from abroad can be exempted from punishment" "GMP, GSP certification after the cancellation of the easier to build a pharmaceutical factory" ...... The newly revised Drug Administration Law (hereinafter referred to as the new law) after the adoption of the review, for a time, the interpretation of the new law is overwhelming.

On September 5, the expert team of the National Drug Policy and Pharmaceutical Industry Economic Research Center (NDPE) of China Pharmaceutical University, which has been deeply involved in the revision of the law since 2013, said in an exclusive interview with a reporter from Science and Technology Daily that the new law should be interpreted reasonably to avoid public misunderstanding.

The penalties for illegal drug purchases abroad remain unchanged.

In 2018, a film about purchasing overseas anti-cancer drugs attracted the attention of public opinion, and discussions and appeals on similar cases were endless.

So, is purchasing drugs from overseas fake drugs, should they be punished and how?

According to the new law, the production and import of drugs without drug approval documents is no longer treated as fake drugs, but it is still prohibited and should bear legal responsibility according to law. At the same time, add "the import of a small amount of drugs that have been legally listed abroad without approval, if the circumstances are relatively minor, may be mitigated or exempted from punishment".

"This is a'sliming' modification of the concept of counterfeit and inferior drugs in the new law, and it is also in line with international standards, but it does not mean that illegal purchasing agents will not be punished." Professor Shao Rong, executive deputy director of the National Drug Policy and Pharmaceutical Industry Economic Research Center, said that no matter what drugs are sold in China, they must obtain an imported drug registration certificate. The fake drugs in the Drug Administration Law before the revision included fake drugs in both practical and legal sense. The situation that drugs purchased abroad for sale in China but without a registration certificate are "treated as fake drugs" belongs to "fake drugs" in the legal sense, but the general public cannot understand or understand them. therefore, incidents similar to the "drug god" will be widely concerned by the society. "The new law responds to this social concern and will no longer be punished as counterfeit drugs, but illegal purchasing agents still violate domestic drug registration regulations. The law also clearly stipulates corresponding penalties, and the penalties have not weakened."

Jiang Rong, a researcher on the NDPE project, said that the new law stipulates that some circumstances can be mitigated or exempted from punishment, but the subjective fault, bad circumstances and consequences of the parties concerned should be considered, and it cannot necessarily be "mitigated" or "exempted".

Encourage innovation while also strengthening regulation

"From an industrial perspective, one of the biggest highlights of the newly revised Drug Administration Law is the'drug marketing authorization holders' system." Shao Rong thinks.

"In the past, China stipulated that only pharmaceutical factories could hold the drug approval documents. Now, institutions such as universities, research institutes and research and development companies can apply to become holders even if they do not build drug production workshops." Liu Pengcheng, a researcher on the NDPE project, said that China's pharmaceutical industry has two major national conditions, one is mainly generic drugs, and the other is overcapacity. Clarifying the drug marketing license holder system from the legal level can not only encourage innovation, but also enable R & D institutions to obtain huge benefits after the drug market, but also integrate resources and digest excess capacity.

So, in the process of R & D institutions entrusting other pharmaceutical factories to produce, how to monitor the quality and how to prevent risks?

In this regard, the new law has set up a "firewall" for the country and holders to detect and control risks in a timely manner: first, a new pharmacovigilance system is added to monitor, identify, evaluate, prevent and control adverse drug events and other drug-related safety issues throughout the life cycle, monitor and evaluate changes in the balance of risks and benefits, and protect public health. The second is to establish a drug traceability system and use information means to track the flow of drugs, realize drug risk control and help precise drug recalls; the third is to add the first responsibility system, so that the entire industry chain of drug research and development, production, and sales can share and resolve drug risks.

"The regulatory authorities will establish a security credit file for holders and increase the frequency of supervision and inspection based on bad records, reflecting the concept of risk-based supervision." NDPE project researcher Xie Jinping said.

At the same time, the new law no longer issues GMP and GSP certification certificates for the production and sales of pharmaceutical companies, but requires them in drug registration, and strengthens supervision and random inspections in production.

"In the past, after the GMP certification was passed, a five-year certification certificate would be issued, but this does not mean that the subsequent production process can continue to be compliant." Shao Rong said.

The new law regards GMP as the basic requirement for the establishment of pharmaceutical production enterprises, and emphasizes in Article 42 that pharmaceutical enterprises should "have rules and regulations to ensure the quality of drugs, and meet the requirements of the drug production quality management standards formulated by the drug supervision and administration department of the State Council in accordance with this law". Article 43 of the new law clearly stipulates the establishment and improvement of a drug production quality management system to ensure that the whole process continues to comply with laws and regulations, and the regulatory authorities implement dynamic inspections.

Tao Tiantian, a researcher of NDPE project, told reporters that after comparison, it can be found that the revision of the legal liability chapter of the "Drug Administration Law" has reached more than 80%, and only 7 clauses have not been revised. At the same time, penalties have also been increased. For example, the ban on business has been extended and the amount of penalties has changed from several times to dozens of times. For example, the amount of fines for the production and sale of counterfeit drugs in Article 116 has changed from "two to five times" to "15 to 30 times", and "if the value of goods is less than 100,000 yuan, it shall be calculated at 100,000 yuan"; article 137 also clearly lists the acts of heavier punishment.

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