News

Last week’s round-up; 4 – 8 May 2020

published 11 May 2020

COVID-19: EMA FAST TRACKS SUPPORT & APPROVAL OF MEDICINES & VACCINES

EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in the inventory https://lnkd.in/deaz5Ki can accelerate every step of a medicine’s regulatory pathway and the Agency is fully mobilised to deliver these fast-track assessments in the shortest possible timeframes while ensuring robust scientific opinions are reached. The text of the press release can be found under https://lnkd.in/d-qhK4B

EXPEDITED REVIEW FOR A PIP, DEFERRAL OR WAVIER FOR TREATMENTS AND VACCINES FOR COVID-19

In particular, EMA will review applications for a PIP, deferrals or waivers for treatments and vaccines for COVID-19 in an expedited manner, in order to speed up an approval. The compliance check can also be expedited, if needed. For these products,

      1. No pre-specified PIP submission deadlines;
      2. Review of a PIP is reduced to a minimum of 20 days;
      3. EMA decision following a review is reduced to 2 days;
      4. Compliance check can be reduced to 4 days.

 

There is also a possibility for the developer to provide a focused scientific documentation, to be agreed on a case-by-case basis. Full details can be found under this link https://lnkd.in/d2SRyn8

UPDATED SAWP 2020 MEETING DATES

EMA’s Scientific Advice Working Party (SAWP) has updated meeting dates in September 2020. The full tabulations under link https://lnkd.in/djmCNCP include deadlines for submissions for scientific advice, protocol assistance, qualification of biomarkers and parallel consultation EMA/EUnetHTA requests.

ICH Q3C (R6) RESIDUAL SOLVENTS

An updated draft of the impurities guideline for residual solvents, ICH Q3C (R8), has been published. ICH Q3C recommends acceptable amounts for residual solvents in pharmaceuticals, and this draft only contains information on three additional solvents: 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol.

The Permitted Daily Exposure (PDE) for each has been set at 50mg/day, 15mg/day and 35mg/day respectively. The document is open for consultation until 30 July 2020. Once agreed upon, this data will be integrated into a complete ICH Q3C (R8) guideline document: https://lnkd.in/gEh9PGU

CLINICAL PHARMACOLOGY AND PHARMACOKINETICS: Q & A

The EMA has released a new Clinical pharmacology and pharmacokinetics Question & Answer. The new Q&A (4.12) clarifies the EMA’s position on the demonstration of bioequivalence for the anticoagulant drug dabigatran etexilate. The following clarifications are provided:

        • A bioavailability study under fed conditions may not replace the comparative bioavailability study with proton pump inhibitors.
        • Dissolution tests at various pHs may not replace the comparative bioavailability study with proton pump inhibitors.
        • Demonstration that the effect of proton pump inhibitor on the bioavailability of dabigatran is equal or less than for the innovator product, is not sufficient.

 

Bioequivalence should also be demonstrated in the presence of proton pump inhibitors. Further details are available here: https://lnkd.in/ghYb-vP

NEW MODEL OF GI TRACT COULD SPEED DRUG DEVELOPMENT

A promising new model of the gastrointestinal tract could speed up drug development. Created by MIT engineers, the model tests how well drugs are absorbed in the small intestine and should help oral drug formulation. The model uses pig intestinal tissue, and more closely replicates the human intestine than the currently used approach of testing these formulations in human colorectal cancer cells.

The system can be used to test up to 10,000 samples per day and its results have been found to be 90% accurate, through tests carried out using 60 drugs already approved by the FDA. In contrast, tests using colorectal cancer cells have a near 50% percent accuracy: https://lnkd.in/gRiw-zy

FDA DRAFTS GUIDANCE ON EMERGENCY-USE INJECTOR RELIABILITY

The FDA has released draft guidance explaining how combination product developers can demonstrate that their emergency-use injectors will reliably deliver drugs as intended in a life-threatening emergency. The draft guidance specifically applies to emergency-use injectors that are prefilled or co-packaged with emergency drugs or biologics. The document expands on FDA’s ‘Technical Considerations for Pen, Jet, and Related Injectors for Use with Drugs and Biological Products’ guidance that was released in 2013.

The “FDA recommends that emergency-use injectors include design control specifications for successful injection reliability of 99.999% with a 95% level of confidence”, which ensures that the emergency-use injector performance is as safe and reliable as possible as well as feasible. The guidance also provides a model for establishing reliability and recommendations for completing a reliability report to submit premarket submissions for these products. https://bit.ly/3dlH6xs

EC: Q & A ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING COVID-19

The European Commission has released some new questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. The document includes the following guidance (questions 2.2 – 2.4) on the manufacturing and importation of finished products and active pharmaceutical ingredients:

    • 2.2: Measures that will be taken in respect of GMP certificates and authorisations to manufacture/import due to difficulties in conducting on-site GMP inspections due to restrictions linked to the current pandemic.
    • 2.3: Measures that will be taken in respect of GDP certificates and wholesale authorisations due to difficulties in conducting on-site inspections due to the pandemic restrictions.
    • 2.4: Adaptations to the work of QPs that are possible considering travelling and other restrictions arising from the pandemic.

 

The EC has released the above guidance in order to prevent disruptions in the availability of medicines during the pandemic. https://bit.ly/2VYSVnu