Russia. The Government accepts amendments to the Federal Law “On Circulation of Pharmaceuticals”

At the Government session held on June 26 the draft federal law on introducing amendments to the Federal Law “On Circulation of Pharmaceuticals” was endorsed in respect of adjustment of conceptual framework, addition of new terms, including terms covering interchangeable, orphan, biologic, innovative drugs and reference drugs.

The draft law envisages the following:

• Establishing the procedure for monitoring compliance of pharmaceuticals production with the rules of medicines manufacturing and quality control;
• Changing the list of documents composing the registration dossier; determining the conditions under which no bio-equivalence study for generic drugs is required;
• Procedure for confirming the interchangeability of pharmaceuticals for medical use;
• Empowering the federal executive bodies to adopt “good practices” in the field of clinical and pre-clinical trials and sales of pharmaceuticals.

The document is to enter into force on the 1st of January 2015.

Source: pharmvestnik.ru