The UK’s statutory scheme revision for branded medicines
by Giuliana Miglierini The amendment of the statutory schemeregulating the increase in pricing and consequent clawback payments of…
EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…
Consultation on the reform of the European pharmaceutical legislation
In November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The Pharmaceutical Strategy identifies flagship…
Draft guidelines, open for consultation
ICH guideline Q13 on continuous manufacturing of drug substances and drug products This guideline describes scientific and regulatory…