EMA - Lättnader i regelverket

Europeiska läkemedelsmyndigheten (EMA) aviserar lättnader i regelverket för små och medelstora företag vid exempelvis kliniska prövningar (forskning på nya läkemedel). Åtgärden riktar sig specifikt till mindre företag inom kategorin Medical Devices (medicintekniska produkter,ex instrument) som inte har de finansiella resurserna att möta tidigare krav.

EMA updates SME guide to reflect clinical trial reporting requirements

Regulatory News | 24 January 2024 

The European Medicines Agency (EMA) has updated its user guide for small and medium enterprises (SME) based on new requirements coming into effect under the EU Medical Devices Regulation (MDR). It touches on issues such as clinical trial requirements, use of the agency’s IT systems, addresses products with regulatory framework uncertainty, and more.
 
On 23 January, EMA republished its user guide for SME’s that updated sections based on new requirements under MDR. The guide is specifically catered to SMEs that may not have the resources of larger companies to specialize in EMA regulations and emphasizes requirements that are specific to their needs.
 
The biggest update to the document addresses clinical trial regulations and the agency’s Clinical Trials Information System (CTIS). EMA notes that previously, sponsors were required to submit clinical trial information separately to countries in the EU or European Economic Area (EEA), but now they can transition to the CTIS, where individual countries can retrieve the information, which will be phased in over the next few years.
 
EMA said it foresees a three-year transition period to implement CTIS requirements under the 2014 Clinical Trials Regulation. The agency has already required sponsors to submit initial clinical trial applications, starting last year. Now, it says all ongoing trials that were approved under the Clinical Trials Directive before 31 January 2023 will have to transition their data to CTIS and conform to the new regulation by 31 January 2025.

Major update of the SME user guide

• Information System (CTIS)
• Medical Devices Regulation (new section 4.8): offers insights into the medical devices regulation for human medicines
• Borderline Products (section 3.6): Guidance on products with regulatory framework uncertainty
• Big Data (section 4.3.6): Guidance on utilising big data for decision making

Min kommentar
Huruvida detta gynnar PHI i något avseende beträffande just nu bedriven forskning i Europa är osäkert.

Det som dock är säkert är att företag som PHI kommer få lättare att sälja in sina instrument till labb och forskare i Europa. 

En fråga av högt intresse är om denna regeländring underlättar och påskyndar Bolagets högprioritetsmål att bli GMP-godkända. ( Good Manufacturing Practise ) Skulle så vara fallet tror jag alla förstår dess betydelse för framtida möjligheter till införsäljning av HoloMonitor.

Reflektion: Hoppas alla phi,are noterar de positiva tecken som på senare tid kommit in,alla i Bolagets favör.

                                              Mvh the99