Moreover, most of the existing databases (i.e., OMIM, Human Gene Mutation Database (HGMD), CTD, and PharmGKB ... GPP is Full Member and National Representative at the European Medicines Agency, ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public health interest.

From 31st January, 2025, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are ...

The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications. The clinical overview and clinical summaries in ...

The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...

Of those, more than 5,000 trials were transitioned onto the new CTIS from the CTD. Additionally, the EMA added that trials which are ongoing and have not been moved to the new system may be ...

From the beginning, Player 831 (Jeff Allen) has been upfront about his mission: to win the money and find a cure for his son’s CTD (Creatine Transporter Deficiency). This genetic disorder is ...

The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications. The clinical overview and clinical summaries in Module 2 ...