ZisNews - Breaking News & Updates

NEw new delhi, India's do drugs regulator has directed manufacturers and importers to defer periodical refuge Update Reports for new drugs from the date of actual marketing of the product rather than from the date of regulatory approval, in a move aimed at strengthening post-marketing safety surveillance.In an advisory issued by the Central Drugs Standard Control Organisation on April 21, the regulator said it has observed instances where companies obtained approval for a new drug but launched the product in the market much later while submitting PSUR data from the approval date instead of the launch date.The CDSCO said such a practice results in the loss of "valuable safety insights" that are critical for monitoring adverse effects and ensuring patient safety after commercial roll out of medicines.Under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, manufacturers and importers are required to submit PSURs as part of post-marketing drug safety monitoring."In view of the above, all manufacturers/importers are hereby directed to ensure strict compliance," the advisory stated.According to the regulator, PSUR submission timelines will now commence from the date of actual marketing of the new drug "even if approval was granted earlier".The advisory by the Drugs Controller General of India also said that ordinarily all dosage forms, formulations and indications for a new drug should be covered in a single PSUR to avoid duplicate submissions.However, separate presentation of safety data for different dosage forms, indications or patient populations should be included within the same report, it added.The directive has been circulated to stakeholders as well as CDSCO's zonal and sub-zonal offices.PSURs are critical documents used by regulators worldwide to assess the risk-benefit profile of medicines after they enter the market and help identify adverse drug reactions that may not have emerged during clinical trials.This article was generated from an automated news agency feed without modifications to text.

Global News Perspectives

In today's interconnected world, staying informed about global events is more important than ever. ZisNews provides news coverage from multiple countries, allowing you to compare how different regions report on the same stories. This unique approach helps you gain a broader and more balanced understanding of international affairs. Whether it's politics, business, technology, or cultural trends, ZisNews ensures that you get a well-rounded perspective rather than a one-sided view. Expand your knowledge and see how global narratives unfold from different angles.

Customizable News Feed

At ZisNews, we understand that not every news story interests everyone. That's why we offer a customizable news feed, allowing you to control what you see. By adding keywords, you can filter out unwanted news, blocking articles that contain specific words in their titles or descriptions. This feature enables you to create a personalized experience where you only receive content that aligns with your interests. Register today to take full advantage of this functionality and enjoy a distraction-free news feed.

Like or Comment on News

Stay engaged with the news by interacting with stories that matter to you. Like or dislike articles based on your opinion, and share your thoughts in the comments section. Join discussions, see what others are saying, and be a part of an informed community that values meaningful conversations.

Download the Android App

For a seamless news experience, download the ZisNews Android app. Get instant notifications based on your selected categories and stay updated on breaking news. The app also allows you to block unwanted news, ensuring that you only receive content that aligns with your preferences. Stay connected anytime, anywhere.

Diverse News Categories

With ZisNews, you can explore a wide range of topics, ensuring that you never miss important developments. From Technology and Science to Sports, Politics, and Entertainment, we bring you the latest updates from the world's most trusted sources. Whether you are interested in groundbreaking scientific discoveries, tech innovations, or major sports events, our platform keeps you updated in real-time. Our carefully curated news selection helps you stay ahead, providing accurate and relevant stories tailored to diverse interests.

Drug regulator asks firms to file safety reports from actual launch date of new drugs

Global News Perspectives

Customizable News Feed

Like or Comment on News

Download the Android App

Diverse News Categories

Category News

Country News