Country-specific requirements and maintaining documents containing different quality information for the same product have always been challenging. Excessive inventory segregation, the likelihood of manufacturing and Regulatory compliance errors, and varying submission, evaluation, and deployment deadlines all add to the complexity of product supply chain regulation worldwide. As a result, various legal frameworks around the globe are focusing on implementing innovative modifications or enhancements to increase process efficiency and robustness.
Life sciences is a highly regulated industry, full of sensitive information that is required to be maintained efficiently. Documents are the backbone of any life sciences segment since it establishes the quality of processes and assurance of safety. The growing volume of documents in organizations exponentially increases the demand to replace traditional and manual documentation practices to reduce time, effort, and errors. In such scenarios, the absence of a proper Document Management System (DMS) increases the chance of misplacing critical documents and tracking changes significantly.
For years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant PDFs, performing quality checks, compiling documents for submissions, and troubleshooting issues related to submissions.
Moreover, pharmaceutical companies are under immense pressure to submit error-free documents within stringent timelines. The inability to meet the timelines delay the product launch.
The need for life-saving drugs is on a constant rise. Owing to novel diseases proving fatal, drug manufacturers are spending a lot of time and money on the research and development of chemical and biological drugs. As challenging as inventing Innovator drugs is, it can be equally daunting for manufacturers to register them.
Following the Brexit on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocidal products. The existing EU Biocidal Products Regulation (EU BPR) has been transformed to Great Britain Biocidal Product Regulation (GB BPR). However, most aspects of the EU BPR will continue in the same way under the GB BPR.
Here are a few updates on the GB BPR:
The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc. Let us have a look at what Brexit means for the EU and the UK Regulatory Submissions. Here is a clear-cut Brexit impact summary that has recently been published by a consulting firm.
Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval. When filing Investigational New Drug (IND)/ New Drug Applications (NDA) to the USFDA, medical writers are obliged to develop high-quality documents by collating all nonclinical, clinical and scientific data in a standard, comprehensive, and logical manner for Agency’s review.
Aligning with all the global health authorities, the Jordan Food and Drug Administration (JFDA), too, has started accepting marketing authorization submissions in electronic common technical document (eCTD) from March 1, 2019. The new format – JO eCTD Format – has similar elements of other health authorities eCTD formats? Obviously not.
The impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’. Coming to the scenario of Life Sciences regulations, if the UK leaves the European Union (EU) with a no-deal, the former will no longer be a member of the EU medicines and medical device Regulatory networks.
Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region. Therapeutic Goods Administration (TGA) of Australia has rolled out a new mandate to use latest version 3.1 Module 1 Specification for Regulatory submissions post June 30th, 2018.