Europe – New agreement places Northern Ireland regulation back in the UK
Regulation of human medicines in Northern Ireland now are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MRHA) under an changes...
USA – FDA issues draft guidance on pulmonary tuberculosis drugs
The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to...
International – ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
The objective of this guideline is to recommend acceptable amounts for residual solvents in
pharmaceuticals for the safety of the patient. The guideline recommends use...
International – Generic industry group wants clarity on ICH bioequivalence guideline
The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...
USA – Dual draft guidances outline FDA vision for pediatric drug development, exclusivity
In a move that could ruffle the feathers of pharmaceutical companies, the US Food and Drug Administration (FDA) says it aims to be more...
International – ICH releases Q9 training materials on quality risk management
The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the...
UK – Children and teenagers with an aggressive form of brain cancer set to...
A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young people with an aggressive form of brain cancer,...
Europe – Addendum to the guideline on the evaluation of medicinal products indicated for...
This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to...
Europe – Biosimilar medicines can be interchanged
EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference...
UK – Research provides hope for patients with neurodegenerative disease
Scientists have discovered a new treatment that slows the progression of neurodegenerative disease in mice. The breakthrough research may offer hope in tackling currently...
