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The new "Pharmaceutical Management Law" was released. Experts called for a correct interpretation.


"A film changed China's "Drug Administration Law"" "Illegal purchase of drugs from abroad can be exempted from punishment" "It is easier to build a pharmaceutical factory after the GMP and GSP certifications are cancelled"... The newly revised Drug Administration Law (below) After the deliberation and approval of the new law, the interpretation of the new law was overwhelming.

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

The illegal punishment of illegal drug purchase abroad remains unchanged

In 2018, a film about purchasing anti-cancer drugs abroad caused public opinion concern, and discussions and appeals on similar cases were endless.

Then, if you buy medicine from abroad, it is not a fake medicine. Should you punish it and how to punish it?

According to the new law, the production and import of drugs that have not obtained the drug approval certificate are no longer based on counterfeit drugs, but they are still prohibited acts and should bear legal responsibility according to law. At the same time, it is possible to increase or decrease the number of drugs that have been legally listed outside the country without approval. If the circumstances are relatively light, they can be alleviated or exempted from punishment.

"This is a new method of 'slimming' modification of the concept of counterfeit drugs and inferior drugs. It is also an approach to international standards, but it does not mean that there is no penalty for illegal purchases." Shao, Executive Deputy Director of the National Center for Drug Policy and Pharmaceutical Industry Economics Professor Rong said that regardless of the drug, as long as it is listed and sold in China, it is necessary to obtain an import drug registration certificate. The counterfeit drugs in the former Drug Administration Law were revised to contain counterfeit drugs in the actual sense and in the legal sense. Drugs that have been purchased overseas for domestic sales but have not obtained a registration certificate are regarded as “fake drugs” in the legal sense, but the general public cannot understand or understand it, so it is similar to the 'medicine god' event. Widely concerned by the society. "The new law has responded to this social concern and is no longer treated with counterfeit drugs. However, illegal purchases still violate domestic drug registration regulations, and the law clearly stipulates corresponding penalties. The penalties have not diminished."

Jiang Rong, a researcher at the NDPE project, said that the new law stipulates that some situations can alleviate or exempt penalties, but it is necessary to consider the subjective faults of the parties, the bad plots and the consequences, and cannot necessarily “reduce” or “exempt”.

Encourage innovation while strengthening regulation

“From an industrial perspective, one of the biggest highlights of the newly revised drug management law is the ‘one drug listed license holder’ system.” Shao Rong believes.

"In the past, China only required pharmaceutical companies to hold drug approval documents. Now, universities, research institutes, research and development companies and other institutions can not apply for a drug production workshop." NDPE project researcher Liu Pengcheng said that China The pharmaceutical industry has two major national conditions, one is generic drugs, and the other is overcapacity. Clearing the drug listing license holder system from a legal level can not only encourage innovation, but also allow R&D institutions to obtain huge benefits after the listing of drugs, and integrate resources to digest excess capacity.

Then, in the process of entrusting other pharmaceutical companies to produce in the R&D institutions, how should the quality be monitored and how should the risks be prevented?

In this regard, the new law has established a “firewall” for the state and holders to detect risks and control risks in a timely manner: First, a new drug alert system to monitor drug adverse events and other drug-related safety issues throughout the life cycle. Identify, assess and prevent and control, monitor and evaluate changes in risk-benefit balance, and protect public health; second, establish a drug traceability system, use information technology to implement tracking drug flow, achieve drug risk control, and assist in accurate drug recall; The first responsible system allows the entire industry chain of drug research and development, production and sales to share and resolve drug risks.

“The regulatory authorities will establish a holder's safety credit file and increase the frequency of supervision and inspection based on bad records, reflecting the concept of risk-based supervision,” said Xie Jinping, researcher at NDPE.

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

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

The new law regards GMP as the basic requirement for the establishment of pharmaceutical production enterprises. In Article 42, it emphasizes that pharmaceutical companies should “have rules and regulations for ensuring the quality of pharmaceutical products, and comply with the requirements for the quality management of pharmaceutical products formulated by the drug regulatory authority under the State Council in accordance with this Law. ". In Article 43 of the new law, it is clearly stipulated to establish and improve the production quality management system for pharmaceuticals, to ensure that the whole process continues to comply with laws and regulations, and the regulatory authorities implement dynamic inspections.

NDPE project researcher Tao Tiantian told reporters that after comparison, it can be found that the revision of the Legal Liability section of the Drug Administration Law has reached more than 80%, and only seven articles have not been revised. At the same time, it has also increased penalties, such as the extension of the period of imprisonment and the amount of punishment from several times to dozens of times. For example, Article 116 of the penalty for the production and sale of counterfeit drugs is from the value of goods. The amount of "more than twice and less than five times" has become "five times or more and thirty times less". "If the value of the goods is less than 100,000 yuan, it is calculated at 100,000 yuan"; it is also clear in Article 137. List the behaviors that are heavily penalized.

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