Good progress in Denmark-China collaboration

01 July 2019

The Danish Medicines Agency’s collaboration with the Chinese drug regulatory authorities has entered a new phase, reaching agreement on specific collaboration projects among which a project on quality control of radiopharmaceuticals.

Last week, the joint steering group of the Danish-Chinese inter-agency collaboration in the pharmaceutical area approved a specific working plan for the next couple of years’ activities in the Denmark-China inter-agency collaboration in the pharmaceutical area.

The steering group includes representatives of the Danish Medicines Agency, the Department of the Danish Ministry of Health, the Danish Embassy in Beijing and, from China, representatives of the National Medical Product Administration (NMPA), the Chinese drug-regulatory authority.

The working plan defines the scope and nature of the activities which the authorities plan to carry out together in Denmark and China, respectively, and some have already begun.

Laboratory control of radiopharmaceuticals is one of the focal points of the collaboration.

“Denmark is the only country in the EU that has a drug regulatory authority that can carry out laboratory tests on radiopharmaceuticals, and it is therefore of great value that we can exchange experience with China, which also carries out quality control of radiopharmaceuticals,” said Deputy Director General Jakob Cold, who co-chairs the steering group.

This week, the Danish Medicines Agency will be welcoming representatives from the National Institutes for Food and Drug Control, the Chinese authority responsible for quality control of medicines. The purpose of the visit is to prepare a project on comparative measurements of a radiopharmaceutical in the laboratories in Denmark and China, respectively, to see if they reach the same results. The project is scheduled to run in autumn.

In the area of documenting the quality in clinical trials, a workshop has already been completed. In addition, workshops have been held in the spring in Beijing on the framework for medical devices in China and Denmark/EU, where new regulations are under way.

In autumn, an activity on the documentation and assessment of biological medicines and biosimilars is also planned to take place as well as a workshop on advanced therapy medicinal products (ATMP) and on the requirements for and assessment of API dossiers.

Deputy Director General of the Danish Medicines Agency Jakob Cold, chairman of the steering group, said: “I am very satisfied that we are making steady progress in our collaboration with China. We share a mutual, professional interest that drives us, and we have an extremely sound basis for acquiring new insights as well as reflections on how we do things in Denmark and China, respectively, to ensure effective medicines and optimum patient safety”.

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