The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) signed a memorandum of understanding (MOU) with the China Food and Drug Administration (CFDA) during a visit to China last week.
The agreement, signed by MHRA chief executive Dr Ian Hudson, pledges new areas of cooperation and the exchange of information from the UK’s Accelerated Access Review on the regulation of medicine sold online.
Both countries also reviewed their existing cooperation, building on an MOU signed in 2014, which focused on the exchange of medical safety information.
The latest agreement was signed while Hudson was accompanying UK Prime Minister Theresa May on an official visit to China to promote ‘global Britain’ ahead of the upcoming Brexit deadline in March 2019. It was signed in Beijing’s Great Hall of the People with May and China’s Premier Li Keqiang present.
Hudson said: “China is a world leader in the market for raw materials for the pharmaceutical industry and closer collaboration with MHRA will support the promotion of innovation, good practice, and protect UK patients.
“We operate in a global environment and formalising our international relationships helps strengthen regulatory systems to protect public health worldwide.”
The agreement could prove significant if the UK leaves the European Union without reaching an agreement with the European Medicines Agency (EMA). Without being aligned with a larger, multinational regulatory body, the UK risks falling behind in the licensing of new drugs.
Although drug firms are pushing for the UK to remain part of the EMA, in the event of a ‘hard Brexit’ where no deal is reached, the UK could align itself with another regulatory bloc such as the CFDA.
With the majority of drug ingredients manufactured in China and India, Western regulators are increasingly looking for ways to form relationships with China’s pharmaceutical industry.
The US Food and Drugs Administration (FDA) has an established working relationship with the CFDA. In 2014 the two regulators signed an Implementing Arrangement which saw the US triple the number of FDA staff in the country and increase the number of FDA inspections of drug manufacturing facilities.
China is also pursuing greater standardisation in global drug regulation and joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in 2017. It is also restructuring its clinical trials system to be similar to the FDA’s Investigative New Drug process.