Category: Regulatory

FDA Updates Forms FDA 1571 and FDA 356h: Key Changes FDA has released updated versions of Form FDA 1571 (05/2026) and Form FDA 356h (05/2026) to support PDUFA VII requirements and improve data quality and usability.

What Is Regulatory Submission Planning? Regulatory Submission Planning is a process that allows the pharmaceutical, biotechnology, and medical devices sector to better organize and manage all the activities related to regulatory submissions.

What Is Multi-Region Drug Registration? Multi-Region Drug Registration refers to the process of getting approval from the regulatory body for the marketing of the medical drug in multiple locations.

What Is Lifecycle Regulatory Strategy? The Lifecycle Regulatory Strategy refers to a systematic method of dealing with the regulatory obligations of a given pharmaceutical product as the regulatory needs arise over the product lifecycle.

What Is an Environmental Risk Assessment Report for Molecules? The Environmental Risk Assessment Report for Molecules is a report which is prepared to assess if and how a certain kind of pharmaceutical molecule can affect the environment.

EDQM Regulatory Update PA/PH/CEP (14) 06, 2R: Guidance on Using an Intermediate CEP in a Final Substance CEP Application The revised EDQM Regulatory Update PA/PH/CEP (14) 06, 2R guideline clarifies how a valid Certificate of Suitability (CEP) for an intermediate (CEP X) can support a CEP application for a final substance (CEP Y).

What Is Regulatory Inspection? Regulatory inspection is an official study that is performed by a government or some regulation entity in order to check the good compliance of the pharmaceutical company, laboratory, manufacturing enterprise, or any other regulated institution with rules, laws, and quality requirements.

What Is Health Canada Drug Approval? Health Canada drug approval is a process through which pharmaceutical companies will get the permission to sell their medicines in Canada. Health Canada checks the scientific facts to see if the drug follows relevant standards of safety, efficacy and quality.

What Is TGA Regulatory Approval? In Australia, the process of obtaining TGA regulatory approval entails the assessment and regulation of therapeutic goods. The Therapeutic Goods Administration (TGA) is the overseeing body in Australia that provides oversight in the regulation of medicines, medical devices, biologicals, and any other therapeutic goods.

What Is CDSCO Approval? CDSCO approval is the regulatory process through which medicines, medical devices, and certain other healthcare products are evaluated and regulated for the Indian market.