MHRA, CFDA Sign MoU on Drug, Device Regulation

MHRA, CFDA Sign MoU on Drug, Device Regulation

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the China Food and Drug Administration (CFDA) on Wednesday signed a memorandum of understanding (MoU) to exchange information on new areas of drug and medical device regulation.

The MoU was signed by MHRA Chief Ian Hudson and CFDA Director Bi Jingquan during UK Prime Minister Theresa May’s visit to China. Both May and Chinese Premier Li Keqiang presided over the signing.

According to MHRA, the MoU will focus on exchanging information learned from the agency’s Accelerated Access Review (AAR) and on how best to regulate the sale of medicines online.

The new MoU also builds on a 2014 agreement between the two countries to exchange safety information about drugs and devices.

“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,” said Hudson.

For its part, CFDA has made strides in the last year to update its regulation of drugs, medical devices and clinical trials, and recently joined the International Council for Harmonization (ICH) as a regulatory member.

The agreement also comes as the UK and EU prepare to enter the next round of Brexit negotiations. While the two parties have adopted guidelines and outlined their goals for the continued talks, the specifics of how the UK and EU will interface on drug and device regulation post-Brexit are still being worked out.

SOURCE:-.raps.