The Danish Medicines Agency contributes to review of Chinese medicines act

10 October 2017

Chinese delegation visits the Danish Medicines Agency

On Monday 9 October, a Chinese delegation headed by Xu Jinghe visited the Danish Medicines Agency.

The cooperation between the China Food and Drug Administration (CFDA) and the Danish Medicines Agency continues at full momentum after the state visit in May when the Chinese and Danish Ministers for Health signed a Memorandum of Understanding.

On Monday 9 October, a Chinese delegation headed by Xu Jinghe visited the Danish Medicines Agency. Xu Jinghe is Director General of the CFDA’s Department of Legal Affairs and one of the main architects of the renewal of the Chinese medicines legislation.

The revised medicines act provides an important answer as to how 1.4 billion Chinese will get access to safe and accessible medicines, and how China as an industrial nation becomes one of the global players in the pharmaceutical field.

As at previous meetings, the Chinese approach was characterised by great honesty and pragmatism. They attach crucial importance to defining relevant and critical issues that the legislation must provide the answers to.

Some of the issues discussed with the Danish Medicines Agency were about how Europeans are dealing with a risk-based approach, how complaints may be escalated in various systems, the scope of responsibilities of a marketing authorisation holder, and how audits and accreditation of the Danish Medicines Agency are made.

Tuesday, our Chinese colleagues continued their search for possible design elements to the regulatory reform. The delegation visited a Danish pharmacy (Sønderbro Apotek), a pharmaceutical wholesaler (Tjellesen Max Jenne) and Novo Nordisk north of Copenhagen.

The dialogue with our Chinese colleagues encourages us to reflect on our own premise of the regulatory role, organisation, processes etc. This dialogue will continue in November when several of our inspectors are travelling to Beijing to elaborate on the risk-based approach and the procedures for conducting various types of inspections.

The CFDA’s presentation of their work with the regulatory reform was conceptually impressive. The objectives for China as a life science nation and a global player are extremely ambitious. They are pursuing a long-term strategy and are making massive investments.

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