On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities.
EMA, FDA and TGA joint GMP inspection programme
Home/Guidelines
|
Posted 13/05/2011
0
Post your comment
The objective of the collaboration on GMP inspections is to spread the workload, allowing more API sites to be monitored.
The EMA and FDA had already announced a pilot programme for joint GMP inspections in August 2010 and had prepared a draft procedure for such a joint venture in September 2010. Adding Australia’s TGA to the collaboration will certainly help to spread their resources further, enabling even more sites to be inspected.
The idea of collaboration to lighten the load is not new for the EMA and FDA. The agencies launched a three year pilot programme on 1 April 2011 that will allow parallel evaluation of quality elements, known as Quality by Design, of selected applications that are submitted to both agencies at the same time.
Related articles
FDA and EMA to join forces on quality
Source: EMA, FDAnews
Policies & Legislation
NPRA Malaysia trials new timelines for variation applications
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
Reports
Top nine biological drugs by sales in 2023
New findings of semaglutide in managing hidradenitis suppurativa
Related content
Regulatory update for post-registration of biological products in Brazil
Home/Guidelines Posted 29/10/2024
FDA interchangeable biosimilars guidance update on revised approach to switching studies
Home/Guidelines Posted 23/07/2024
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Post your comment