EU Medical Device Regulation Technical Documentation Structure and Requirements
The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements.
Anvisa signs agreement with European Medicines Agency (EMA)
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
EMA waives fees for orphan drug consultations
European Medicines agency (EMA) updates their executive decision for orphan drug development of waiving fees for academic organizations.
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
EMA waives GMP inspection fees during COVID-19
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.
EMA FAST TRACKS FOR MEDICINES AND VACCINES DURING COVID-19 PANDEMIC
On May 4, 2020, The European Medicines Agency (EMA) details the rapid approval procedures for COVID-19 products which includes scientific advice, rolling reviews, accelerated assessments.