Make Sure You Get The Real Registration Strategy But Not A Quotation


Registration strategy is a roadmap to the success of NMPA approval. It relies heavily on the input information provided by the manufacturer and the experience of the consulting company from the perspective of the registration process, cases of similar products approved in China, the mastery of past and current regulations, and the judgment of new policies. A qualified consulting company should help clients find a balance between the client’s needs and NMPA requirements at the strategy phase, such as the registration unit, indication, clinical requirements/pathways, standards, testing requirements, and any potential risks along with the registration. The consulting company shall also be able to communicate with the NMPA reviewer on behalf of the manufacturer.
Takeaway: Some consulting companies only provide a simple quotation disguised as a registration strategy, which will be revised or even overturned in the later registration process.