Regulatory Affairs
DCP vs. MRP | Choosing the Right Regulatory Pathway in the EU
Navigating the European regulatory landscape can be complex, especially when seeking approval for medicinal products across multiple countries. Two key procedures streamline this process: Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP). While both facilitate multi-country approvals, understanding their differences is essential for strategic regulatory planning. Decentralized Procedure (DCP) DCP ... Read More
Handling Conflicting Regulatory Requirements | A Strategic Approach
In global regulatory affairs, one of the most complex challenges we face is resolving conflicting requirements from different regulatory bodies. Each agency has its own set of expectations, shaped by regional regulations, scientific perspectives, and risk tolerance. Navigating these differences requires a strategic, risk-based approach to ensure compliance while maintaining ... Read More
Permeability and Biowaivers | A Key Factor in Regulatory Justification
For obtaining a biowaiver based on permeability, regulatory authorities like USFDA, EMA, and WHO require a justification report that classifies the drug according to the Biopharmaceutics Classification System (BCS). This classification determines whether a drug is eligible for a biowaiver based on high solubility and high permeability (BCS Class I) ... Read More
Understanding Patent Length and Generic Competition in Pharmaceuticals
Hello everyone! I’ve been preparing to share more insights on pharmaceutical regulations in the future, and today I’ve learned about patents, FDA approvals, and how generics enter the market. How Patent Protection Works Patent Duration FDA Approval Time What Happens After the Patent Expires? Generic Drug Applications Market Exclusivity for ... Read More
Legal Basis for Marketing Authorization in the EEA
Navigating the regulatory landscape for drug approval in the European Economic Area (EEA) can be complex. There are multiple legal pathways, each with its own requirements, especially around clinical studies. Here’s a quick snapshot: Full Applications (Article 8(3) of Directive 2001/83/EC) require comprehensive clinical data for new products. Generic Applications ... Read More
FDA NDA Classification Codes
Understanding New Drug Application (NDA) Classification Codes is crucial for setting clear regulatory and development timelines. These codes help the FDA categorize new drugs based on their relationship to previously approved therapies. The numerous acronyms used by the FDA, along with their distinct meanings, can be quite confusing. Beyond its ... Read More
Differences Between eCTD and ACTD Dossier
eCTD (Electronic Common Technical Document) ACTD (ASEAN Common Technical Dossier) Key Differences Read also: Resource Person: KABYA PRATAP ROYAL
Understanding the FDA 483 Warning Letter
FDA Form 483 = Official notification issued at the conclusion of a facility inspection when FDA investigators identify conditions that may violate the FD&C Act and related regulations. Consists of observations regarding practices that may lead to the adulteration of products or pose health risks. Navigating the FDA 483 Warning ... Read More
A Brief Overview of the 505 Regulatory Pathways
The FDA recognizes three primary pathways for the approval of new drugs and abbreviated new drug applications (ANDA): the 505(b)(1) NDA, 505(j) ANDA, and 505(b)(2) NDA. Each pathway serves a distinct purpose in the drug approval process. 505(b)(1) NDAThe 505(b)(1) NDA is a comprehensive application that relies entirely on original ... Read More
505(b)(2) Submission Process
The 505(b)(2) submission journey involves four crucial steps: candidate identification, candidate assessment, product planning, and the pre-IND meeting. Candidate IdentificationThe first step involves selecting drug products compatible with the 505(b)(2) pathway, a crucial action that mitigates the risk of failure. It typically involves a few nonclinical studies. During Phase 1, ... Read More