Antimicrobial Drugs Clinical Study Regulations Harmonization
The FDA, EMA and PMDA aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.
FDA Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics
OVERVIEW Companies developing novel drugs or biologic products for rare diseases or other life-threatening diseases can now plan clinical studies for Investigational New Drugs (INDs) to establish their drug or biologic candidate’s effectiveness and explore strategies reduce to their time to market with New draft guidance from FDA. GUIDANCE: ‘Providing Evidence of Effectiveness of Human Drug […]
Drug Master File (DMF) in China
The new system set up by the NMPA allows manufacturers to file the DMF directly, thereby reducing the approval time and respective cost involved.
China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases
Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have alread…
China New Policy Pushing Generics over Brands
On Tuesday April 3rd, 2018, the Chinese government published a new policy that promotes the usage of generics over brands in China. As an incentive, the qualified generics companies will be considered as high-tech enterprises, and therefore will be imposed a corporate tax rate of 15% instead of 25%. Additionally, generic that pass the quality […]
FDA-First Agency to Release a Guidance on 3D Printed Products
To keep up with evolving 3D printing technology and to encourage and support innovation in this field, the FDA has released it first technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue. The guidance provides a comprehensive policy framework to manufacturers and a more efficacious pathway to […]