China has been implementing reforms of drug registration review and approval since 2015, including a variety of regulations issued to improve the quality of generic drugs. Under the new regulatory framework, the quality and efficacy consistency evaluation of generics has been put into force, the Abbreviated New Drug Application (ANDA) requirements have beenimproved and harmonized…
A Whole New Game? Innovation and Regulation in China and Switzerland Switzerland is home to a highly innovative life sciences cluster. Many multinational corporations, as well as a network of smaller companies and startups have operations in Switzerland, mostly in the Basel Area. The industry is vibrant, with many innovative developments occurring in pharmaceuticals, biotech…
Mandatory GACC registration for all F&B exporters from 1 January 2022 On 8 December 2021, the EU SME Centre and its leading consortium partner, the China-Italy Chamber of Commerce, held their webinar on new major regulations from the General Administration of Customs of China, which require all overseas F&B manufacturers exporting to China to have…
Date: Wednesday, 8th December, 2021 Time: 4 – 5:30 (Beijing） Time: 9 – 10:30 AM CST (Brussels) Price: Free of charge Click here to register. You will then receive an invitation to this webinar. Please note that the number of participants is limited. TOPICS and SPEAKERS: In April 2021, China’s General Administration of Customs (GAC)…
China pharmacovigilance regulations have been undergoing significant reform reinforced by recently issued Good Pharmacovigilance Practices (GVP) (2021, Decree No. 65). In addition to the regulations, the National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE) and National Centre for Adverse Drug Reaction (ADR) Monitoring (NCADRM) of China have also released guidelines and standards for…
Animal testing is conducted on animals such as rabbits (usually in Chinese labs) and guinea pigs. This is toxicological testing for reactions such as eye irritation or skin irritation, A majority of overseas brands from Europe, America, Australia, and New Zealand are cruelty-free and don’t do animal testing. But China, as a huge…
Date: Tuesday, 9th March, 2021 Time: 7:30 AM – 8:30 AM CST (China Standard Time) Price: Free of charge Click here to register. You will then receive an invitation to this webinar. Please note that the number of participants is limited. TOPICS and SPEAKERS: Pete Frost: Trade Commissioner, Greater China, New Zealand Trade & Enterprise…
Join free webinar on China Drug Master File (DMF) Filing for APIs, Excipients & Packaging Materials (click here to register) on Thursday 15th April, 2021, at 10:30 CEST time. The webinar will provide an overview of the requirements, regulatory pathways, how to register your DMF in China and a comparison between US FDA and EMA…
