The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market there are many regulatory milestones and hurdles. Following are some tips to assist with up-front planning to prevent headaches down the road.
Challenges with regulatory policies in China that make entry difficult and costly are causing outside pharma companies to hesitate to expand their global footprint into the country, despite strong government support for innovation. This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage chemistry, manufacturing, and controls (CMC) changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
Advanced therapy medicinal products (ATMPs) are medical products for human use, often used in regenerative medicine. There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
This e-book provides an illustration of the cutting-edge presentations from BioProcessing Asia 2018, from the sustainability of biosimilars to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production.
Fast Trak: Services from molecule to market
GE's Fast Trak services will help you to increase productivity, reduce costs, and bring your products to market faster. With a comprehensive portfolio of services including cGMP manufacturing, process development, and training, Fast Trak gives you the tools and know-how you need to solve biomanufacturing challenges and optimize your process.