Category: Regulatory

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.

What Is EMA Drug Approval? EMA drug approval is a type of regulatory process to evaluate medicines for the purpose of its use in markets of Europe. The European Medicines Agency (EMA) would assess all scientific evidence related to the quality, efficacy, and safety of the drug so that it can be authorized in one… Continue reading What Is EMA Drug Approval?

What Is FDA Drug Approval? FDA drug approval refers to the procedure in which the FDA assesses a novel medicine to ascertain whether it is effective and safe for the targeted objective. This procedure requires thorough research, trials, and the assessment of the approaches used by the relevant authorities before a drug can be offered… Continue reading What Is FDA Drug Approval?

What is a Master Validation Plan (MVP)? In the pharmaceutical industry, maintaining product quality, regulatory compliance, and patient safety is non-negotiable. A Master Validation Plan (MVP) serves as the foundation for organizing and controlling all validation activities within a manufacturing facility.

What is Post-Market Surveillance? Post-Market Surveillance (PMS) is a crucial process in the pharmaceutical industry that ensures medicines remain safe, effective, and compliant even after they are launched in the market.

What is a DHF(Design History File)? Developing pharmaceutical products requires more than innovation, it demands complete documentation, regulatory compliance, and unwavering quality assurance.

FDA Announces Generic Drug User Fee Rates for Fiscal Year 2027 (FY 2027) The U.S. Food and Drug Administration (FDA) has released the FY 2027 Generic Drug User Fee Rates published under the Generic Drug User Fee Amendments of 2022 (GDUFA III). These fees are used to cover FDA review of generic drug applications, Drug… Continue reading FDA Announces Generic Drug User Fee Rates for Fiscal Year 2027 (FY 2027)