European Medicines Regulatory Network has now issued a draft guidelines on the electronic Submission Roadmap for medicinal products for human and veterinary use across the Europe Union.
The key objective of the norms is to establish a secure, consistent and efficient electronic submission processes. Factors that would enable timely implementation of the roadmap is to come to a common agreement of National Competent Authorities and the European Medicines Agency (EMA) to create consistent eSubmission architecture for the Network.
A number of initiatives have been undertaken to enable and improve the added value of eSubmission within the Network. For instance, EMA mandated eCTD for applications of Centrally Authorized Products (CAP) for human use from 2010. The Network developed structured electronic Application Forms and set up a Common European Submission Platform (CESP). These initiatives have been achieved with the support of the pharmaceutical industry.
According to Kaushik Desai, past chairman Industrial Pharmacy Division, Indian Pharmaceutical Association, Indian pharma should respond to the e: submissions which is seen an ideal platform to ensure speedy registration of their medicinal products for human and veterinary use. The companies will also have a better understanding and better clarity on the regulation.
The increase of regulatory requirements introduced by legislation has put the Network under strain and interoperability of systems has become the key for efficient use of data and resource. There was a need for the Network to establish a clear roadmap that would enable pharmaceutical industry and regulatory authorities to plan for the necessary investments and organisational changes, said the regulatory authority.
In the current budgetary climate it is paramount for the Network to find ways to save human and financial resources to cope with the increasing regulatory workload and the electronic processes resulting from the implementation of the eSubmission Roadmap shall help the Network to work more efficiently, stated the regulator.
In support of administrative, regulatory and scientific activities related to medicinal product regulatory applications the main objective of the eSubmission Roadmap are secured electronic handling of regulatory information for all procedures throughout the life cycle of medicinal products. It is electronic processing without paper or any physical media.
It implementation of a single electronic exchange message for submission of regulatory information for medicinal products, in line with international standards. Further, it is one single entry point for submission of applications to all authorities.
The objectives of the Roadmap should be achieved as a result of coordinated development and supported by clear and appropriate communication with stakeholders at international, European and national level.
The EU Telematics Strategy of the Network has a broader scope and supports other regulatory activities involving electronic exchange of different types of regulatory information throughout the life cycle of medicinal products, e.g. clinical trials, pharmacovigilance, inspections, among others.
The eSubmission Roadmap is a high level strategic plan for business and technology change, typically operating across multiple disciplines over several years. It is a tool to help pharmaceutical industry to prepare themselves to forthcoming changes.
Although electronic submission of applications within the Network has increased, the uptake of a standard electronic format is slow. In the human sector, e:submission is widespread, but a non-standard e:submission is still used as an alternative format for submission of applications for medicinal products for human use. In the veterinary sector paper submissions are still common across the Network, but a specific e:submission has become the reference in the European Union for electronic submission for medicinal products for veterinary use.