China eases generic medicine import laws

Home/Policies & Legislation | Posted 20/09/2019 post-comment0 Post your comment

China has revised its drug administration laws to allow the import and sale of small quantities of generic drugs which are not approved in China. 

Law V13C29

Under the revised law, the Chinese government will no longer classify generic drugs that are legal in foreign countries but unapproved in China as ‘fake medicines‘. People bringing these drugs into China without official approval will be granted leniency if the amount of drug is small, and they will be exempt from punishment provided the drug does not cause health problems or delays in treatment. Previous laws classified people importing unapproved medicines as drug smugglers, and those caught faced heavy penalties.

This revised law was passed by the Standing Committee of National People’s Congress in August 2019 to tighten supervision in the pharmaceutical market following many fake drug and vaccine cases, which triggered calls to improve drug safety.

Chinese state media said the move could help more people access generic drugs from countries such as India without waiting for the approval of official regulators.
‘This new move is significant because it redefines “fake or counterfeit drugs“ by focusing on their safety and efficacy, not on whether they obtain government approval,’ wrote Dr Yanzhong Huang, a senior fellow for global health on the Council on Foreign Relations, in an email.

‘Under the new definition, a cheaper generic drug made in India can be imported and sold in China,‘ Dr Huang wrote. ‘Given that these drugs are usually much cheaper than the prohibitively priced Western patented drugs, a significantly larger percentage of Chinese people can now afford those lifesaving drugs‘.

This revision in the law follows the 2018 box office hit ‘Dying to Survive‘ which highlighted the need for affordable medicines in China, and led to the Chinese Government reducing tariffs on 28 drugs including anticancer drugs from India.

While this move will help patients access generic medicines, people who want to import generic drugs for business purposes will still be required to follow current Chinese laws and register and obtain approval in advance.

In addition to tightening supervision in the pharmaceutical industry, the revised law will also encourage innovation in the research and development of new drugs.

‘The law underscored China’s commitment to pharmaceutical research and development in the general rules section and added or improved over 10 clauses to encourage innovation,‘ said Liu Pei, a senior official with the National Medical Products Administration.

The new ruling will take effect on 1 December 2019.

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