News & Events - Real Regulatory

20 Sep 2021

Last week’s round -up;
13 -17 September 2021

New EMA Product-Specific Bioequivalence Guidance
The EMA has adopted the following new product-specific bioequivalence guidance, which come into effect on the 1st November 2021:
· Acenocoumarol, tablet, 1 mg and 4 mg
· Lapatinib film-coated tablet 250 …

Last week’s round -up;
06 -10 September 2021

August 2021
Real CMC Tips and Insights

Last week’s round -up;
30 August – 03 September 2021

August 2021
Real Regulatory Tips and Insights

Last week’s round -up;
23-27 August 2021

Last week’s round -up;
16-20 August 2021

Last week’s round -up;
09-13 August 2021

Last week’s round -up;
02-06 August 2021

July 2021
Real CMC Tips and Insights