Some topics of the regulations

Regulatory milestones

In general terms and using the FDA and EMA nomenclature (see respective guidelines), regulatory milestones are e.g.

• for FIH trials: investigative new drug (IND) application or clinical trial applications (CTA)
• for marketing approval: new drug approval (NDA) or biologics license application (BLA) and marketing authorization application (MAA)

Special rules apply for orphan drugs (FDA: roughly 6 in 10'000 people; EMA: at the most 5 in 10’000 EU people), Emergency Use Authorizations (FDA, EUA), etc.

The IND is part of the dossier of the investigative medicinal product dossier (IMPD, EMA), which also includes sections on quality, manufacture and control (also called chemistry, manufacturing and control = CMC).

Consultations

Consultations with regulatory authorities are encouraged and partly regulated in special documents (see e.g. the EMA document).

Good Laboratory Practice (GLP)

There are specific regulations for working according to Good Laboratory Practice (GLP), a must for regulatory development, see e.g. the regulations of EMA.

However, preclinical safety done for research support and other non-pivotal preclinical investigations including a number of ADME investigations do not have to be GLP-compliant. Exceptions for pivotal studies, e.g. for investigations done at universities, are possible if adequately justified.