Regulatory Focus

The European Medicines Agency (EMA) has published a guideline on evaluating drug interactions in the gastrointestinal tract that addresses situations in which extrinsic factors in the gastrointestinal tract may affect drug absorption.

A recent report from the European Medicines Agency (EMA) highlights that global regulators are strongly committed to sharing plans for good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) suppliers yet have made only moderate progress toward sharing inspection reports in recent years. Joint inspections remain a challenging area, evidenced by a 50% decrease compared to the previous reporting period.

Singapore’s Parliament has advanced legislation to build “a more coherent, future-ready system” that provides clarity and predictability for the healthcare industry.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA said it wants to conduct research into perceived barriers to enrolling women in pregnancy exposure registries, the agency announced priority review voucher fees for the next fiscal year, and it named permanent leaders to three of its product centers.

Top US Food and Drug Administration (FDA) officials said the agency is open to novel, “innovative approaches” to the clinical development of psychedelic drugs in light of the worsening mental health crisis in the US.

The European Medicines Agency (EMA) has updated a guideline on good pharmacovigilance practice (GVP) inspections to reflect changes to the rules on subcontractors.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.