News & Regulatory Updates

15 | December | 2022

  • FDA | U.S Regulatory | FDA’s Oncology Center of Excellence encourages researchers to respond to a recently published Request for Applications (RFA) to receive funding for projects aimed at developing and implementing new approaches to support drug development for ultra-rare paediatric and adult cancers. Click here for more details.

09 | December | 2022

  • EMA | Europe Regulatory | EMA and the European Centre for Disease Prevention and Control (ECDC) join forces to strengthen the continuous monitoring of vaccines in the EU.
  • FDA | U.S Regulatory | FDA has amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. Learn more.
  • FDA | U.S Regulatory | U.S.FDA releases a list of augmented reality and virtual reality (AR/VR) medical devices legally marketed in the U.S. through 510(k) clearance, granted De Novo request, or Premarket Approval. Click here for details..

08 | December | 2022

  • EMA | Europe Regulatory | The EMA gives extreme priority for safety of COVID-19 vaccines authorised in the European Union (EU). As this helps for the detection of any rare side effects that may emerge once many millions of people are vaccinated. The EMA updates safety information of COVID-19 vaccines.
  • EMA | Europe Regulatory | Are you a sponsor for clinical trial or planning to sponsor any clinical trial in future Then you should know that EMA is improving the way clinical trials are regulated. Watch the video.

07 | December | 2022

  • TGA | Australia Regulatory | TGA now makes Pharmacovigilance Inspection Program (PVIP) metrics report for 2021. TGA also mentions that this report provides a high-level overview of inspection deficiencies identified during 2021, including a comparison of deficiencies identified in the previous reporting periods. Click here for more details.

01 | December | 2022

23 | November | 2022

  • EMA | Europe Regulatory | Do you like to know how can Artificial Intelligence be used in medicines development and regulation? Read the article.

15 | November | 2022

  • EMA | Europe Regulatory | The Real World Evidence are very important for regulatory decisions on medicines globally This conclusion was the result of a study performed jointly by the University of Groningen and the European Medicines Agency (EMA) Data Analytics and Methods Task Force, published in the Clinical Pharmacology & Therapeutics journal. Read the article.
  • EMA | Europe Regulatory | If you are a marketing authorization holder of a centrally or nationally authorised medicine in the EU, you can register your Industry Single Point of Contact (i-SPOC) with the European Medicines Agency (EMA). Follow the two steps.
    1. Step 1: Click here to set up an EMA account on the EMA’s IRIS platform,
    2. Step 2: Click here to register your i-SPOC.
  • EMA | Europe Regulatory | Are you a clinical trial sponsor and want to get trained on the Clinical Trial Information System (CTIS) ? EMA offers opportunity to express your interest in gaining access to CTIS Training Environment, also known as CTIS Sandbox, Participate in the ongoing survey.