News & Updates
See below the latest news updates from HiTech Health
HiTech Health can now import and release batches of medicines in the EU
In early January 2020, HiTech Health officially obtained both a Manufacturer’s / Importer’s Authorisation (MIA) licence for Medicinal Products for Human Use (commercial) and an MIA licence for Investigational Medicinal Products for human use (IMPs / clinical trials)....
Continuous Manufacturing: Industry reacts to new FDA guidelines
In February of this year the US Food and Drug Administration (FDA) released a 27-page draft guidance, ‘Quality Considerations for Continuous Manufacturing'. The FDA is seeking to encourage the adoption of continuous manufacturing as the agency believes it can improve...
Key Serialisation Considerations for Orphan Drugs
Adapting company strategies to serialisation Falsified medicines are counterfeit drugs that reach the market illegally. They have not been approved and may contain ingredients which are of poor quality and/or at the incorrect dose. Notably, falsified medicines pose...