News dal mondo
The EU and APIs: New Rules of the Game in Manufacturing
Innovator and generic-drug companies are squaring off on a proposal by the European Commission for an export manufacturing waiver for supplementary protection certificates in the European Union. What are the implications for pharmaceutical companies and manufacturers of active pharmaceutical ingredients (APIs)?...[DCAT]
Industry Comments on ICH Product Lifecycle Management Guideline
The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's...
Fiera Milano ospita Cphi Worldwide 2020
CPhI Worldwide, il più grande evento mondiale dedicato all’industria farmaceutica, tornerà a Fiera Milano dal 13 al 15 ottobre 2020. Il polo...
EU to help boost exports of generic pharmaceuticals
The EU has come a step closer to adopting new rules that will boost the export of generic medicines and biosimilar products to third countries....
TGA Updates GMP Clearance Guidance for Overseas Facilities
Australia’s Therapeutic Goods Administration (TGA) has updated its GMP clearance guidance for overseas manufacturing facilities, providing...