Topic: China Drug Master File (DMF) Filing Agenda: Regulatory Framework & Registration Comparison among China, EU & US Common Challenges Questions and Answers Date and Time: 25th May (wed) 5:00-6:00 pm China time Time: Jun 9, 2022 10:30 AM in Paris Speakers
What’s new for Good Pharmacovigilance Practices (GVP) in China In collaboration with Pharma to Market, join us for a series of two complimentary webinars as we give you an introduction into the latest policy updates on the Good Pharmacovigilance Practices (GVP) in China, Singapore & Malaysia in the final week of May 2022. What’s new…
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…
In collaboration with Accestra Consulting. we invite you to join us for a series of four complimentary webinars in the first 2 weeks of April 2022. Introduction to Generic Drug Registration in Malaysia, Singapore, Vietnam and ChinaThe generic drug registration webinars will cover these topics for each country: Regulatory Framework and Pathways Registration process and…
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…
Part 4. On-site/Distant Inspection and Advisory Meetings Table of contents 1. Drug GMP Inspection. 1.1.On-site Inspection. 1.2. Distant Inspection. 2 CDE Advisory Meetings and Communications. 2.1. Overview. 2.2. CDE Advisory Meetings. 2.3. Fast-track Review Meetings. 2.4. Technical Issue Communications. Drug review and approval challenges in 2020 included overcoming difficulties in completing facility inspection, conducting…
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)…
