Regulatory environment is becoming more and more rigorous Pharmaceutical companies can only survive in transformation and upgrading

With the continuous development of the pharmaceutical industry, the path of transformation and upgrading of Chinese pharmaceutical companies has become clear. The path of the transfer of bulk APIs to specialty APIs and the transfer of specialty APIs to pharmaceuticals is becoming clearer. However, it is worth noting that in the increasingly harsh international regulatory environment, only companies can survive the transformation and upgrading.

In recent years, due to the extensive operation of the pharmaceutical industry, not only has environmental problems worsened, but it has also caused adverse effects of "multiple inputs and half-volume output." The “Twelfth Five-Year Plan” focuses on the future, focuses on transformation and upgrading, and relevant supporting policies also give clear guidance.

The plan stated that by 2015, more than 20 innovative drugs will be cultivated on the market, more than 20 generic new drug varieties with international competitive advantages will be cultivated, and more than 50 modern Chinese medicine varieties will be cultivated. By 2015, more than 50 medical equipment products will be cultivated to master core technologies and form larger market scales.

The goals set by the "Twelfth Five-Year Development Plan" of the pharmaceutical industry are more specific, such as the completion of the transformation and upgrading of more than 200 large pharmaceutical varieties; more than 200 varieties of chemical drug substances have passed the US FDA inspection or obtained the EU Pharmacopoeia Applicability Certification COS Certificate: More than 80 formulation companies have passed GMP certification from developed countries such as Europe, USA, Japan and the World Health Organization; the proportion of formulation exports has reached over 10%, and more than 200 generic pharmaceutical preparations have been registered and sold in developed countries such as Europe, USA and Japan; more than 50 companies Establish R&D centers or production bases overseas.

With the change in the pattern of the world pharmaceutical market, the trend of the regional transfer of international APIs is becoming more and more obvious. For companies, whoever can seize the opportunities will have the future. Therefore, pharmaceutical companies should actively prepare for such measures as raising the level of hardware and software, requiring high-end market drug and government agencies, and transnational pharmaceutical companies to audit factories.

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