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Duty Station:  Kampala, Uganda   About US: Goodman International Ltd is a Pharmaceutical Company based in Kampala – Uganda, dealing in Importation & Distribution of Human and Veterinary Medicines, Agent & Local Technical Representative (LTR) for several Manufacturers from Europe and Middle East. Key Duties and Responsibilities: To handle all National Drug authority (NDA) affairs in co-ordination with staff members of the Regulations & compliance department. Handle and closely follow different company supplier matters related to the following: Product registration and variations Good Manu...

Share this article Share this article SHANGHAI, April 22, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy, has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review. Serplulimab is potentially to be the first anti-PD-1 mAb in MSI-H solid tumors in China. F...

File image BUSINESS NEWS - A Lesotho-based medicinal cannabis cultivator and manufacturer recently became the first African country able to legally export medical cannabis to the European Union (EU).  MG Health got the nod that their manufacturing processes are now officially aligned with the EU’s Good Manufacturing Practice (GMP) standards.  Fewer than 20 companies worldwide have been able to achieve this, which is a “massive achievement” for Lesotho’s economy, MG Health business development manager Luke van der Next said.  “Having a GMP means we can acce...

Nica Richards Fewer than 20 companies worldwide have been able to achieve becoming aligned with the EU’s Good Manufacturing Practice standards. MG Health got the nod that its manufacturing processes are now officially aligned with the EU’s Good Manufacturing Practice (GMP) standards. Picture: iStock A Lesotho-based medicinal cannabis cultivator and manufacturer recently became the first African country able to legally export medical cannabis to the Europe...

1 . LIFE SCIENCES REGULATORY FRAMEWORK 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The primary legislation governing the authorisation, marketing, sale and supply of pharmaceutical products by the US Food and Drug Administration (FDA) is the Federal Food, Drug, and Cosmetic Act (FD&C Act), which has been amended many times over the years to reflect increasing FDA mandates for the regulation of pharmaceutical products. The Public Health Service Act (PHS Act) is the specific authority utilised to approve or license biologic (including biosimilar) products. The primary...