eSA, Inc.’s Post

PMDA: English Version of Biosimilar Q&As On 27 March 2024, Japan's PMDA (Pharmaceuticals and Medical Devices Agency) published an English-language version of its updated recommendations on the quality, safety, and efficacy of biosimilars. The 14-page document, Questions and Answers on Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars, has been updated to reflect the current state of scientific knowledge. The revised sections of the document are indicated and relate to Q&As 9, 10, and 11. >>> read more: https://bit.ly/3xzd2Og #gmpnews #gmp #PMDA #biosimilars #japan

Expanding Generic Drug Access Through International Engagements FEBRUARY 28, 2024 ABOUT THIS WEBINAR FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements. In this webinar, FDA will discuss and provide updates on FDA and EMA’s Parallel Scientific Advice (PSA) Pilot Program for complex generics/hybrid products, address currently available international engagement opportunities, host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA and other global regulatory experts. https://lnkd.in/gAYZkGZD

🔎 Check out this Regulatory Focus article from RAPS on the Remote Regulatory Assessments (RRAs) talks from Day 2 of FDA's Generic Drugs Forum (GDF) 2024. 💡 Learn more by visiting: https://lnkd.in/eyCjeDjx

In Slovakia, the Chamber of Pharmacists (Slovenská Lekárenská Komora   – SLK) runs a #medicineshortages database and independently #monitors and analyses the situation in #pharmacies.   See more #BestPractices from Pharmaceutical Group of the European Union (PGEU) members in addressing medicine shortages at https://lnkd.in/dgjKYNYG Slovak Chamber of Pharmacists

The definition of Unmet Medical Need (UMN) is a provision in the EU Pharmaceutical Legislation. Are you prepared for the implications? DIA Europe 2024 tackled this question in a session now available on-demand for FREE! This session dives into the UMN concept, exploring current perspectives, proposed new definitions from the revised legislation, and future challenges and opportunities. Gain valuable insights to stay ahead of the curve in your regulatory strategy. Watch it today: https://bit.ly/4fblkgY. Looking for more? Mark your calendars for DIA Europe 2025! Stay tuned for updates and check out our website for more information: https://bit.ly/3LmbH19. #DIAEurope #RegulatoryStrategy #UMN #UnmetMedicalNeed #PharmaRegulation

On April 10, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation. We have put together the top 8 takeaways for industry to consider during the next phase of the legislative process: https://lnkd.in/eHFbJksn

🚨 FDA Releases Final Guidance for ANDA Applicants 🚨 The FDA has published a crucial guidance document titled "Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." The guidance outlines the procedures and best practices for organizing and participating in these meetings, which are essential for ensuring that applicants fully understand the FDA’s expectations and requirements for generic drug development. Also, it provides a roadmap for effectively engaging with the FDA, ensuring that applicants fully understand regulatory expectations, which is vital for the successful development and approval of generic drugs. #CRO #FDA #CNRResearch #ANDA https://lnkd.in/gxFZSYhg

Swissmedic: SwissGMDP Database Launched Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies. SwissGMDP lists all valid establishment licence holders and their locations and makes electronic GMP and GDP certificates available. >>> read more: https://lnkd.in/ewvrdcMc #gmpnews #gmp #swissmedic #swissgmdp #database

🔍 Teva v. Amneal case could reshape Orange Book patent listing practices, impacting generic drug approvals in the US. Stay tuned for the Federal Circuit's oral arguments in November 2024. #PatentLaw #GenericDrugs #HatchWaxman #PharmaInnovation

The Drug Regulatory Authority of Pakistan (DRAP) is inviting stakeholder comments on the revised guidance document: “Establishment of Pharmaceutical Unit and Post License Changes”. This document aims to simplify and clarify the regulatory procedures for applicants and firms seeking to acquire, renew, or modify their Drug Manufacturing Licenses (DMLs). DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan. Link to the source: https://lnkd.in/dKJMr8eM