ANVISA Declares Two CSPC Products Exempt from Inspection

May 16, 2020

Due to the COVID-19 impact, many countries’ drug regulatory authorities have postponed the on-site inspection of imported pharmaceutical products, resulting in the advancement of mutual recognition of GMP inspection between countries. Recently, two products of the CSPC entered the Brazilian market without inspection through mutual recognition procedure.

The National Health Surveillance Agency of Brazil (ANVISA) scheduled an inspection of the procaine penicillin and penicillin potassium products produced by the CSPC Zhongrun Company at Liangcun Village between April 27 and May 1, 2020. However, due to the COVID-19 impact, the CSPC was notified of the postponement of the inspection on February 22.

It is no coincidence that many countries have replaced the previous on-site inspection of imported pharmaceutical products since the outbreak of COVID-19. For example, the U.S. announced a deferral of on-site inspections; South Korea announced a switch from on-site inspections to paper audits; Japan has also postponed inspections or shifted to paper audits; the EU announced permission for applications for delayed CEP registration.

In such situation, the CSPC predicted that mutual recognition of GMP inspection between countries would be advanced significantly in the near future.

As expected, the group received a notice from ANVISA on March 18 that the inspection would be conducted under mutual recognition.

The CSPC, which had already obtained the EU’s GMP certificates for procaine penicillin and benzathine penicillin products, displayed its competitiveness for globalization. Only one day after receiving the notice from ANVISA, its drug registration team provided the necessary documents as requested.

On April 21, the CSPC’s procaine penicillin and penicillin potassium products were approved to enter the Brazilian market, rapidly opening up a pathway for the group’s presence in the country.

In recent years, the CSPC has continued to implement its global strategy and align with international quality standards, obtaining 12 CEP certificates and 35 DMF registration numbers. Twenty-five products of the group have passed the FDA’s on-site inspection.

In the era of COVID-19, the CSPC, as a pharmaceutical manufacturer, is working with its counterparts in various countries to fight against the pandemic. Obtaining international certification helps the group export quality, effective and safe drugs to meet the needs of patients in the globe; it is also a manifestation of the CSPC’s mission of “All for better medicine, all for a healthier world”.

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