UK’s exiting the European Union not only raises questions about the regulatory and administrative complications for pharma and life sciences companies, but can also drain organizational resources. Digital transformation backed with a cutting edge EQMS solution will be crucial to navigate regulatory challenges around Brexit.
Brexit may have been postponed to 31 October 2019 from March 2019, but the challenges for healthcare and pharmaceuticals industry remain the same – to anticipate regulatory implications of this exit and prepare to meet them when the time comes.
The European Medicines Agency (EMA) and the European Commission have provided guidance for pharmaceutical companies to enable them to continue to supply medicines to the EU without disruption. The EU has mandated that each marketing authorisation holder (MAH), national competent authority and EMA operate a pharmacovigilance system to detect, assess, understand and prevent any adverse effects or other medicine-related problems.
Currently, the EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission.
Impact across the lifecycle: from product development to market approval
A PricewaterhouseCoopers monitor points out that the pharma and life sciences industry will be impacted in areas ranging from product development to market approval to the shipping of medicines and medical devices following Brexit. While uncertainty will impact the industry in the UK, it will also have a fallout on the industry as a whole in other European geographies as well.
In case of a ‘no deal’ exit by UK, it will become a ‘third country’ and will be out of the European Economic Area (EEA). This will require UK-based companies to comply with EU requirements to continue supplying after Brexit. MAHs are required to transfer their batch testing site from the UK to the EU27/EEA by the date. In case of their inability to do so, they will be allowed a grace period to complete the transition up to the end of this year. The MAHs will have to share their timetable for transferring the quality control testing site.
Impact on Innovation
Brexit will deny UK companies access to the EU’s Research and Innovation programs such as Horizon 2020 till the terms of UK’s contribution to the programs is finalised. Till such time, key research projects may be transferred outside the UK to be able to participate in international research programs.
UK had been a popular centre for clinical trials in the EU, but it looks like that is going to change. Additionally, new EU Clinical Trials Regulation have become mandatory since 2018, to enable pan-European clinical trials. With Brexit, UK would no longer be a part of it, making the participation of British firms in these trials more difficult, time consuming and expensive as separate trials maybe needed for the UK.
IP rights and administration will also become more complicated, raising questions about applicability of UK patents in EU and vice versa. This will entail the pharmaceutical and life sciences companies to manage their IP portfolios keeping in mind their geographical validity/enforceability of their IP rights. Separate patent applications may be required, increasing not only the administrative cost but also needing time to go through the processes.
Such demands on time and resources will not only divert the attention of organizations from their core business, but can also prove expensive if not handled right.
ComplianceQuest, an EQMS built on the Salesforce.com Platform, caters to just such compliance needs in an ever-changing environment. It can be tailored to meet the regulatory changes of organizations catering to the UK and EU geographies. The product enables a customer to have a top-down approach to enforce SOPs, Quality System Regulations (QSR), ISO requirements and other best practices. Needless to add, Document Management for regulatory needs can also be stored in a single, easily accessible repository.
At CQ, we have several years of experience in serving the healthcare, pharmaceutical and life sciences segment, and our world-class EQMS built on the real cloud can help navigate this evolving regulatory ecosystem with efficiency. We will also bring to the table our specific domain expertise in quality and compliance systems, knowledge of regulatory frameworks and best practices to drive efficiency and productivity into the compliance process.
To request for a demo or know more, click here: http://www.compliancequest.com/