The National Medical Products Administration (NMPA) implemented the Priority Review Program and Approval Procedure as a Regulatory pathway that would help expedite the review and approval process for drugs that have major public needs and offer significant clinical benefits or have breakthrough therapeutic effects.
It also helps accelerate Research and Development (R&D) and the launch of new medicines with significant clinical value. Under this program, the NMPA assigns a dedicated review team to assess the drug application. The team consists of experts who prioritize the review process and ensure a faster evaluation as compared to the standard review timelines.
The Priority Review Program is also expected to reduce the assessment period for products. There are six (06) categories of priority review designations. The products that fall under “Category 1” are as follows:
Category 1
- Innovative new drugs and new dosage forms which used for the prevention and treatment of serious infectious diseases and rare diseases, for which there is an urgent clinical need.
- Drugs with additional indications and new dosage forms that are compatible with the physiological characteristics of children.
- Vaccines and innovative vaccines that are urgently required to prevent or control diseases.
- Drugs that are designated as breakthrough therapies.
- Medicinal products that are reviewed under the Conditional Approval Procedure.
- Other drugs that NMPA designates for priority review.
The Priority Review Program aims at reducing the review process timeline by up to six (06) months, thereby enabling pharmaceutical companies to bring their medicines to the market faster. Freyr will help you get approval from NMPA on your innovative products without any hassle.
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