ARTICLES

China-ICH

All You Need to Know about CFDA Joining ICH

By Amanda Mao, 05-July-2017

China Food and Drug Administration (CFDA) was approved as a new regulatory member of the ICH in May/ June 2017. Below we at Acurit Medical Communications translate and edit information from various sources in Chinese to analyse this milestone and its impact on the sector. We especially highlight changes and trends most relevant to international companies.

Medical Device

Fact or Fantasy—New CFDA Draft Regulations on Drugs and Medical Devices

By Amanda Mao, 18-May-2017

On 11 and 12 of May 2017, China Food and Drug Administration (FDA) announced on its official website four new draft regulations on drugs and medical devices. All drafts are currently inviting public comments. We translate the main contents from Chinese into English, focusing on the possible impact on overseas companies.

 

China Aged Care

High-Quality Aged Care Products in Demand in China

By Amanda Mao, 12-Apr-2017

In China, old-age dependency ratio will increase from the current 2.8:1 to 1.3:1 in 2050. On the other hand, the aged care industry still needs to be revitalised. Senile finance, supplies, services and real estate are all in infancy, with huge potential to grow.This, in turn, leaves massive room for aged care businesses overseas to plan their China market entry.

 

China-FDA

China FDA Adjusts Registration Requirements for Imported Drugs

By Amanda Mao, 20-Mar-2017

On 17 March 2017, China Food and Drug Administration (CFDA) announced on its official website a new draft regulation on registration of imported drugs. Insiders believe that after implementation, this regulation will bring about far-reaching and profound effects for China pharmaceutical market. Below is the main content translated into English, as well as analysis of policy indications.