European Nitrosamine Regulations – EMA/511347/2019
Are you aware of new European Nitrosamine Regulations - EMA/511347/2019. There is serious workload expected from all marketing authorisation holders (MAH) in EU! Let’s see what is expected for MAH
Biological and Biosimilar Medicinal Products
What is a biological medicinal product? A biological medicinal product is a medicinal product that contains an active substance produced or excreted from biological sources (human, animal, or microbiological). Due
Update about ANVISA´s role in pharmaceutical patent applications
In August 2017, the Brazilian Health Surveillance Agency (ANVISA) published Resolution No. 168/2017, which establishes the administrative procedures related to ANVISA´s “prior consent” for the granting of pharmaceutical patent applications,
Are You Free to Price Pharmaceuticals Products in South America?
On average, big pharmaceutical companies spend around 20% of their budget in research and development of new drugs. For smaller companies, the effort can be even higher, up to 50%
How to Detect Digital Health Scams?
Have you heard about this? The scam: Stealing more than $500,000 from buyers eager to acquire a miracle wearable. The product: BioRing, a device that was supposed to do everything
MHRA – GxP Data Integrity Guidance for Industry
MHARA has publised GxP data integrity guidance for the industry. It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of
European “One-Stop-Shop” for Regulatory and Market Access Support
FarmavitaR+ is not only platform for on-line hiring of consultants, experts and freelances. We are also "one-stop-shop" for complex international projects. To manufacturers of pharmaceuticals, biopharmaceutucals and medical devices, we offer
Turkey – Growing Market and Pharmaceutical Hub
As you all knew, at the end of July 2016, Turkey has suffered a failed coup attempt. After that the government took some serious even excessive measures to clean
New European Regulations for mHealth apps
The Draft of Code of Conduct on privacy for mobile health apps has now been formally submitted for comments to the Art 29 Data Protection Working Party. Once approved by
Ethical Advertising of Medicinal Products
The EFPIA HCP Code covers all methods of promotion including, but not limited to, oral and written promotional activities and communications, journal and direct mail advertising, the activities of Medical