New Drug Administration Law to Be Implemented Soon
On the morning of August 26, 2019, the 12th Session of the Standing Committee of the 13th National People's Congress passed the newly revised Drug Administration Law with 164 votes in favor and 3 abstentions. The law will take effect on December 1, 2019.
This is the first comprehensive revision of the Drug Administration Law in 18 years. Addressing key social concerns such as imported drugs, innovative drugs, and online drug sales, relevant officials responded at a special press conference held by the General Office of the Standing Committee of the National People's Congress on the 26th.
Encouraging Innovation and Accelerating New Drug Launches from an Institutional Design Perspective
The newly revised Drug Administration Law explicitly stipulates in its general provisions that the state encourages the research and creation of new drugs. It adds and refines more than 10 articles, introducing multiple institutional measures, including a dedicated Chapter 3 on "Drug Marketing Authorization Holders," which comprehensively and systematically regulates the conditions, rights, obligations, and responsibilities of holders.
The so-called marketing authorization holder system refers to a mechanism where drug research and development institutions and manufacturing enterprises that own drug technologies apply for drug marketing authorization, obtain a drug registration certificate, market the product in their own name, and assume responsibility for the entire life cycle of the drug.
"This is a key focus of the new revision of the Drug Administration Law," said Liu Pei, Director of the Policy and Regulations Department of the National Medical Products Administration. The marketing authorization holder is also the producer or the licensed entity. The system ensures accountability for the entire life cycle of drugs, stimulates market vitality, encourages innovation, and optimizes resource allocation.
In November 2015, the 17th Session of the Standing Committee of the 11th National People's Congress authorized the State Council to pilot the drug marketing authorization holder system in 10 provinces and cities including Beijing. Over the past four years, it has achieved positive results, playing an active role in strengthening management throughout the drug life cycle, encouraging innovation, reducing low-level duplication, and optimizing resource allocation.
During the process of revising the Drug Administration Law, the National People's Congress summarized pilot experiences, refined scientific regulatory systems, established a dedicated chapter, and clearly defined the primary responsibility of marketing authorization holders for drug quality and safety in relevant chapters. This strengthens regulation throughout the entire process and provides legal safeguards for implementing corporate primary responsibilities.
In the general provisions, the Drug Administration Law explicitly states that the state implements the marketing authorization holder system for drugs. Marketing authorization holders are legally responsible for the safety, efficacy, and quality controllability of drugs throughout the entire process of research and development, production, distribution, and use. At the same time, it stipulates that marketing authorization holders must establish a quality assurance system and be responsible for all processes and links, including non-clinical studies, clinical trials, production and distribution, post-marketing studies, adverse reaction monitoring, reporting, and handling. In addition to possessing quality management and risk prevention and control capabilities, marketing authorization holders must also have compensation capabilities. For overseas marketing authorization holders, they must clearly designate a domestic corporate legal entity in China to fulfill the holder's obligations and bear joint liability.
While clarifying the responsibilities of holders, the Drug Administration Law also makes a series of provisions for drug research and development units, manufacturing enterprises, distribution enterprises, and user units, requiring strict compliance with legal provisions during production, distribution, and use to ensure that information throughout the entire process is authentic, accurate, complete, and traceable.
Yuan Jie, Director of the Administrative Law Office of the Legislative Affairs Commission of the Standing Committee of the National People's Congress, added that the drug marketing authorization holder system has a major benefit: it encourages innovation from an institutional design perspective. In addition to manufacturing enterprises, research institutions that develop new products should be able to reap substantial benefits after the product is launched.
Unapproved Importation of Legitimate Drugs No Longer Treated as Counterfeit Drugs
The story in the movie Dying to Survive (I Am Not the God of Medicine), where the protagonist exclusively agents the Indian generic drug "Gleevec," along with this year's Liaocheng counterfeit drug case, has sparked widespread public attention to the social issue of purchasing overseas anti-cancer new drugs.
Does purchasing overseas anti-cancer new drugs count as counterfeit drugs? Should they be penalized, and if so, how? The newly revised Drug Administration Law addresses this highly concerning social issue.
Article 124 of the law clearly stipulates: The importation of foreign legitimate new drugs not yet approved domestically will no longer be treated as counterfeit drugs; for the unapproved importation of small quantities of foreign drugs that have been legally marketed abroad, penalties can be reduced if the circumstances are minor; and if no personal injury consequences or treatment delays occur, penalties can be exempted.
Excerpted from People's Daily Online
