Ireland’s Health Products Regulatory Authority (HPRA) has updated two guidances, on good distribution practices (GDP) and wholesaling of medicinal products for human use. Read more “Ireland’s HPRA revise two guidances”
Category: Medicinal product
New measures to support safe use of stimulant laxatives
The Medicines and Healthcare products Regulatory Agency (MHRA) have introduced pack size restrictions, age warnings and new safety warnings on labelling of over-the-counter (OTC) stimulant laxatives such as bisacodyl and senna. Read more “New measures to support safe use of stimulant laxatives”
Post-transition guidance from the MHRA: Licensing
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements regarding pharmaceutical and biological product licensing. Read more “Post-transition guidance from the MHRA: Licensing”
The impact of the orphan and paediatric regulations
The European Commission (EC) has published results from an evaluation of the EU orphan and paediatric regulations. Read more “The impact of the orphan and paediatric regulations”
FDA details final guidance on marketing status notifications
The US Food and Drug Administration (FDA) has issued a final guidance clarifying expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale. Read more “FDA details final guidance on marketing status notifications”
Highlights from the July CHMP meeting 2020
From their meeting in July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the July CHMP meeting 2020”
Quality considerations for cannabis clinical research
The US Food and Drug Administration (FDA) have released a draft guidance on the conduct of clinical research involving cannabis-derived compounds. Read more “Quality considerations for cannabis clinical research”
Highlights from the June CHMP meeting 2020
From their meeting in June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the June CHMP meeting 2020”
Recommendations to help reduce the risk of impurities in medicines
European regulators have proposed 40 recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities. Read more “Recommendations to help reduce the risk of impurities in medicines”
Highlights from the May CHMP meeting 2020
From their meeting in May, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the May CHMP meeting 2020”