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The "13th Five-Year" plan for the pharmaceutical industry is expected to be released in May.
Date:
06 Feb,2021
The "13th Five-Year" plan for the pharmaceutical industry is about to be released.
Experts involved in drafting the plan reportedly said that the "13th Five-Year" plan for the pharmaceutical industry is expected to be released in May. The document has already completed inter-ministerial review and has been submitted to the State Council for approval.
According to experts involved in drafting the plan, the key word of the pharmaceutical industry's "13th Five-Year" plan is encouraging drug innovation. Specifically, the plan prioritizes including innovative drugs already on the market into the national health insurance catalog, establishing a "green channel" for the approval of innovative medicines, and providing these cutting-edge treatments with policy support and access to industry-specific funding. Ultimately, the goals include enhancing the capacity of medical insurance coverage and guiding pharmaceutical companies toward internationalization by raising industry standards.
In 2016, China was set to launch its generic drug consistency evaluation, and a major industry reshuffle following the evaluation was inevitable. According to the "Opinions on Carrying Out Consistency Evaluation of Quality and Efficacy for Generic Drugs," issued by the State Council, "Generic drugs already approved for marketing in the EU, the U.S., and Japan by domestic pharmaceutical manufacturers can leverage their foreign registration documentation as a basis to apply for new chemical drug registration. Once approved, these drugs will be deemed to have passed the consistency evaluation. Similarly, drugs produced on the same manufacturing line within China, marketed domestically, and simultaneously approved in the EU, U.S., and Japan, will also be considered as having met the consistency standards."
This means that Chinese pharmaceutical companies pursuing an "internationalization" strategy will benefit from streamlined policies in the drug consistency evaluation process, allowing them to secure approval numbers ahead of others and gain a competitive edge in occupying "three key positions." According to the policy, if three or more manufacturers of the same drug have successfully passed the consistency evaluation, centralized procurement processes and other related procedures will no longer consider products that haven’t met the same standards.
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