News

Last weeks round-up; 17 – 21 February 2020

published 24 Feb 2020

NSAI ACHIEVES DESIGNATION TO THE MEDICAL DEVICE REGULATION

The National Standards Authority of Ireland (NSAI) has been approved for designation to the new Medical Device Regulations (MDR). This hugely significant achievement makes NSAI only the 11th notified body in the world to be designated to the new medical device regulation. Further information on this notable achievement can be found here < https://lnkd.in/dx5auvY>

As an NSAI certified ISO 9001:2015 company Real Regulatory congratulates the team at NSAI on the recent approval.

ICH GUIDELINES TO TAKE EFFECT IN EU BY END JULY 2020

EMA has announced that two ICH Guidances – ICH E9(R1) addendum on estimates < https://lnkd.in/dgU3jCr> and sensitivity analysis in clinical trials and ICH S5(R3) on reproductive toxicology < https://lnkd.in/dWApy26> – will take effect in EU on 30 July 2020. The E9(R1) addendum presents a framework for defining an appropriate estimate for a clinical trial and conducting sensitivity analyses.

While the S5(R3) guideline, ICH sets out recommendations for a harmonized approach to assessing nonclinical developmental and reproductive toxicity (DART) testing used to support clinical trials and drug approvals.

REGULATORY FRAMEWORK FOR ATMPS – PROPOSED ACTIONS STATUS UPDATE

EMA has published an updated status on the list of proposed actions to improve the regulatory framework for ATMPs. The complete list can be found under this link <https://lnkd.in/dvx_6RZ>.

Under line item 6, finalisation of the EMA guideline on investigational ATMPs is expected by Q4 2020. It is stated that ‘The Guideline will not change the competence of Member States to approve clinical trials but it will help create common standards for the assessment of these novel products.’ Under line item 7, in relation to the guideline ‘Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (CHMP/ GTWP/671639/2008)’, finalisation is expected by Q2 2020.