GMP News - Regulatory Affairs

The ICH M9 Guideline has reached the consultation step. The Guideline is proposed to address Biopharmaceutics Classification System (BCS)-based biowaivers.

The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.

The US Food and Drug Administration (FDA) recently made available the ICH Q12 draft guidance on "Product Life Cycle Management" together with its Annex.

The European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products. Read more about the updated "Defective product report template".

The FDA recently published its final guidance on liposomes. Read more about the authority's guidance for industry on Liposome Drug Products.

To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.

On 27 November, 2017, the EMA's Committee on Herbal Medicinal Products (HMPC) published the HMPC meeting report about their 79. meeting held from 20-21 November, 2017. Learn more about the key issues discussed during the EMA HMPC meeting.