Bacteria-Eating Virus Approved as Food Additive

Not all viruses harm people. The Food and Drug Administration has approved a mixture of viruses as a food additive to protect people. The additive can be used in processing plants for spraying onto ready-to-eat meat and poultry products to protect consumers from the potentially life-threatening bacterium Listeria monocytogenes (L. monocytogenes).

Bacteriophages are found in the environment. "We're routinely exposed to bacteriophages," says Zajac. "They are found in soil and water, and they are part of the microbial population in the human gut and oral cavity."

Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and response

Drug approvals in the US and Europe have become subject to approval delays, rising requests for further clinical data, and greater chances of rejection. Regulators are currently attempting to reconfigure review processes in order to minimize delays in recognition of the potential mass benefit of new applications.

 Pirates and Corsairs - The difficult equation Pharma-Parallel Trade

“In the legal debate (…), with a little bit of imagination, the undertakings who dedicate themselves to parallel trade could be compared with the pirates and those who defend their intellectual property rights could be compared with the corsairs, who received the “corsair patent” from their Government to attack the ships of the enemy countries.

First FarmavitaR+ / regulanet conference

More than 25 participants met recently in Zagreb to explore and prepare for collaborations with the associates of FarmavitaR+ (FvR+) in Central, Eastern and South-eastern Europe.

Marketing  Authorisation for Medicines via Centralised Procedure in Turkey

Marketing authorisation could be laso granted for Turkey to comapnies on-going cantalised procedure by EMEA, according to investigation of  FarmavitaR+ consultant from Istanbul, Turkey. 

Romania - Tariffs for products authorised through mutual recognition procedure or decentralised procedure

 Ther Framavita.Net members and visitors please be informed that in Romania for registration of medicinal product two separate fees should be paid:

 -one is called tax for evaluation and is in amount of 1000 euros, no matter the type of registration

-the other one is a fee for registration which depends on the type of the application (registration, variation by national procedure/ MRP/ DCP).

New Guidelines about Administrative fees in the Czech Republic 

As of December 1 2007 this new guideline for admistraive fees supersedes guideline UST 29 published in January 2007.

Please, contact us for regulatory affairs support in Czech R., Slovak R., Hungary, Croatia, Serbia, Montenegro, Macednia, Albania, Bulgaria, Romania and Turkey.

Regulatory about cosmetic ingredients

Many of the ingredients used in the cosmetic products are actually industrial strength chemicals, solvents and petroleum by-products. This is even true for many of the most expensive products available and products being promoted as "natural". The truth is that many of the ingredients used widely by cosmetic industry , reason of being used is not that  they are good for your skin.