Regulatory Affairs
Site Master File in Pharmaceutical Industry
In the world of pharmaceutical manufacturing, understanding and maintaining high standards of quality is not just important, it’s imperative. A key element in this quality assurance landscape is the Site Master File (SMF), but what is it? An SMF is a comprehensive document that provides detailed information about the production ... Read More
Differences in Filing for Drug Master File in US, Canada and Europe
In Europe, when filing for a Drug Master File (DMF), the process revolves around stringent regulatory requirements set by the European Medicines Agency (EMA). In the United States, filing for a Drug Master File (DMF) is governed by the Food and Drug Administration (FDA), which has its unique set of ... Read More
Key Steps for Successfully Replying to Dossier Queries
Here’s a strategy chart outlining the key steps for successfully replying to dossier queries. Understand the Inquiry: Review Dossier Contents: Identify Response Components: Organize Response Structure: Gather Supporting Information: Compliance Check: Clarity and Conciseness: Transparency and Honesty: Quality Assurance: Timely Submission: Follow-Up Protocol: Documentation and Recordkeeping: Read also: Resource Person: ... Read More
Comparison Between Generic and Branded Product Regulatory Filings
Generic and branded pharmaceutical companies both undergo regulatory filings as part of the drug approval process. While the overarching goal is to ensure safety and efficacy, there are distinct differences in the regulatory requirements and processes for generic versus branded medications. Regulatory Requirements Generic: Branded: Filing Process Generic: Branded: Timelines ... Read More
ASEAN Common Technical Document (ACTD)
It is a submission format for dossiers used in most ASEAN countries (Association of South-East Asian Nations). The main aim of ACTD is to regulate the pharmaceutical regulations of the ASEAN member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical ... Read More
Estimated Time Frames for Obtaining FDA Authorization
๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ The approval timeline for a biologic can vary depending on the complexity of the product and the data required to support its safety and effectiveness. ๐ฃ๐ฟ๐ฒ-๐๐ก๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years๐๐ก๐: 1-2 years๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐: 3-7 years๐๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 6-12 months๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 5-10 years ๐๐ถ๐ผ๐๐ถ๐บ๐ถ๐น๐ฎ๐ฟ๐ The approval timeline for ... Read More
FDA Requirements For OTC Drugs
An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctorโs prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the ... Read More
Drug Development and Approval Process | Part III
When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as clinical benefit. Mindful ... Read More
Drug Development and Approval Process | Part II
FDA Approval: What It Means FDA approval of a drug means that data on the drugโs effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured ... Read More
Drug Development and Approval Process | Part I
Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). Drug companies seeking to sell a drug in the United States must first test ... Read More