1st May 2018
EMA Scientific guideline: VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use – Revision 1, adopted.
1st June 2018
EMA Scientific guideline: Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD), adopted.
14th June 2018
EMA Scientific guideline: ICH guideline E17 on general principles for planning and design of multi-regional clinical trials – Step 5 – First version, adopted.
1st July 2018
EMA Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis, adopted.
19th July 2018
EMA Scientific guideline: Guideline on the chemistry of active substances for veterinary medicinal products, adopted.
1st September 2018
EMA Scientific guideline: Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease – Revision 2, adopted.
9th February 2019
Commission Delegated Regulation EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.