The US FDA has further revised its guidance on abbreviated new drug applications (ANDAs) and the deficiencies that can cause FDA to refuse-to-receive (RTR) an application. An RTR decision indicates that FDA determined that an ANDA is not substantially complete.
Read more “FDA revises refuse-to-receive guidance for ANDA submissions”
The European Medicines Agency (EMA) will be closed from 23rd December 2016 to 2nd January 2017 inclusive during the Christmas holiday period. However, despite the closure, applications submitted during this period will be accepted but not processed. The agency re-opens on 3 January 2017.
Read the announcement and emergency contact details here.
The Regulis team enjoyed a lovely Christmas meal at a local restaurant last week and celebrated another successful year.
Our opening times over the holiday period will be as follows:
Monday 26th December – closed, public holiday
Tuesday 27th December – closed, public holiday
Wednesday 28th – Friday 30th December – limited working hours, contactable for urgent matters
Monday 2nd January – closed, public holiday
Tuesday 3rd January onwards – normal working hours
We would like to wish our clients and suppliers a very Merry Christmas and a peaceful & prosperous new year. We look forward to continuing to work with you in 2017.
The European Medicines Agency (EMA) will commence a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines. EMA aims to provide developers of biosimilars with advice on the studies and tests they should be performing, on the basis of the quality, analytical and functional data already available for the medicine. This should assist with the stepwise development of biosimilars that is recommended in EU guidelines.
Read more “EMA initiative for tailored scientific advice for the development of new biosimilars”
The MHRA are revealing a different fact about the issue of fake and unlicensed medicines every day in December leading up to Christmas. The agency has created the FakeMeds advent calendar this December to tie in with their ongoing campaign to raise awareness of the risks of fake and unlicensed medical products sold online. A new festive animation is being posted every day on the calendar, which you can view on the MHRA’s website and their Twitter and Facebook pages. Behind each door are Christmas-themed messages about the kinds of products MHRA seize, warnings about potential health risks, or advice on how to buy safely and report suspected fakes.
Click here to read more about this news story and to view the calendar and open the doors, please click here.
This week the European Commission presented the current status of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). The complexities of the new Regulations have become apparent during the English translation process. The Commission has now proposed the following timeframe for 2017:
Read more “European Regulations for medical devices and IVDs to enter in force in May 2017”
The ICH Guideline for residual solvents completed step 5, final adoption by Committee for Human Medicinal Products (CHMP) on 15th December 2016.
This guideline recommends acceptable amounts for residual solvents in medicines with regard to patient safety. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
Read more “CMHP adopts ICH Q3C (R5) guideline for residual solvents”
FDA has issued guidance on publicising medical device “emerging signals” that will see healthcare professionals, the public and consumers receive timely information on medical device risks and potential risks.
The guidance describes the processes and timelines to be followed internal when issuing and updating medical device “emerging signals” notifications. Under the guidance, FDA will notify the public about information that supports a new causal association, a new aspect of a known association between a device and an adverse event, or new information determined by FDA to have the potential to impact patient management decisions.
Read more “FDA to notify the public about ‘emerging signals’ for medical devices”
The EU guideline, dated 10th November 2016, on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins states that “pivotal evidence for similar efficacy will be derived from the similarity demonstrated in physicochemical, functional and pharmacodynamic comparisons.” As such a comparative efficacy trial is not necessary.
Read more “No comparative efficacy study required for Heparin biosimilars”
The European Medicines Agency (EMA) has revised its guidance on the publication of clinical data that came into effect in October of this year. The revised guidance contains a number of changes including:
Read more “EMA updates clinical trial data publication guidance”
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