Brazil delays new rules for governing excipients

Brazil's national medicines regulator has pushed back the implementation of proposed new rules that would govern the manufacturing of excipients.

Brazil's national medicines regulator has pushed back the implementation of proposed new rules that would govern the manufacturing of excipients.

ANVISA wants to implement a new set of good manufacturing practices (GMP) for the pharmacologically-inactive substances, which are often used as carriers for the active ingredients in medications.

To this end, it published draft legislation last year for GMP of all excipients, including a licencing scheme for suppliers and mandatory manufacturing plant inspections.

However, inpharm.com reports that the launch of the proposals was delayed after government officials at the regulator extended the strikes that have characterised much of August and September.

A number of nations are looking to introduce GMP regulations for pharmaceutical excipients, with China due to introduce its own rules in February 2013.

In Europe, the manufacturing of excipients is governed by the Falsified Medicines Directive, which requires the holder of manufacturing authorization to ensure that the agents are suitable for use in medicines through a formalised risk assessment.