In our role as a pharmaceutical service provider and consultancy firm, it is our job to remain up to date with new regulatory developments at all times. It is also our duty to understand them before they take effect, and to be able to interpret and implement them. We are happy to share our knowledge with non-European manufacturers who are looking to gain marketing authorisation for their products in Germany and Europe. At CPhI, Diapharm reaffirmed this commitment by signing a cooperation agreement with the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE).
Despite all the efforts being made to create a common system, the pharmaceutical and healthcare markets in the individual states of the EU remain heterogeneous. Although regulatory authorities are striving for standardisation, they are by no means aiming for simplification, particularly when it comes to clinical affairs, pharmacovigilance and GMP requirements. My CPhI presentation is available for download below.
There is a willingness to comply with the demanding regulations. After all, consumers in China appreciate the high, monitored quality of European goods, and interest in traditional European medicinal products is keen. Because pharmaceutical companies in China have long been familiar with the European GMP guidelines that must be complied with for the export of APIs, the incentive to export finished products – especially traditional Chinese medicine (TCM) – to Europe is now growing. Exchange between the Chinese and European pharmaceutical markets harbours great potential for both sides.
Diapharm’s support has been instrumental in gaining marketing authorisation for more than one-quarter of all herbal medicinal products sold in Europe. As a result, we have particularly deep expertise in this field. We are currently involved in supporting several TCM products on their road to European marketing authorisation. Thanks to our unique knowledge of traditional European and Chinese medicinal products, we at Diapharm are making a contribution to building bridges between both cultures and bringing new life to the pharmaceutical industries on both continents.
At CPhI, I signed the cooperation agreement with CCCMHPIE together with Deputy Director He Chunhong (right).