Challenges in Medic-regulatory writing

Medical writing in regulatory affairs, also referred to as medico-regulatory writing, is one of the most crucial components for obtaining pharmaceutical market approval. Regulatory authorities around the world largely depend on the documents that have been devised by medical writers as they contain necessary scientific and safety information on the product. This is not only applicable to pharmaceuticals but also medical devices, which further strengthens the need for medico-regulatory writing in order to bring the device to the market. However, medical device manufacturers experience challenges when placing the device on the market. Some of these are outlined:


Lack of qualified Medical Writers

One of the main challenges that medical device manufacturers face is finding an experienced and qualified medical writer. They must not only know how to meticulously analyze, effectively present, and communicate the relevant data but also be able to comprehend technical parts of the device and understand the importance of maintaining regulatory compliance with regulations and guidelines. Manufacturers often outsource medical writers that bring such expertise to the table.

Another interesting point is that medico-regulatory and safety writing is largely dependent on the data that is provided, a writer’s skills, and the format of the document. It is important for writers to go beyond the conventional approach to medical writing and incorporate effective results from data analysis, data interpretations and the overall process design. Innovation and creation in medical writing can help facilitate more accurate and engaging documents that are compliant and can communicate important information properly. 

Stringent timeframes & quality

Manufacturers must adhere to the stringent timeframe set by the authorities to obtain approval for their device. This also means that there is little time for document review and revision. Therefore, it is important for medical writers to quickly be able to detect and address any issues that are associated with the device, to ensure quality of the document is not compromised, and incorporate them in the documents which would then need to be submitted within the required timeframe. Regulatory service providers that offer medical writing support must also maintain strict timeframes. 

Changing regulations

Finally, the largest and most impactful challenges is the ever-changing regulations and maintaining pace with them while not compromising on compliance. For example, new regulations as well as updated ones such the In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 and Medical Device Regulations (EU MDR) 2017/745 affect the scope of data and the technical/scientific document requirements- i.e. the Clinical Evaluation Plan and the Clinical Development Plan. Furthermore, under the regulations, post-market safety surveillance have also been highlighted such as PSURs, post-market clinical reports, post market surveillance system reports and more. It is important for medico-regulatory writers to be aware of such changes in regulations. 

Conclusion

The need for outsourcing medical writing work to regulatory consulting organizations is highlighted by the challenges faced by manufacturers. These are related to changing regulations, lack of qualified and experienced medical writers, quality, and strict timeframes. Medico-regulatory writing is a process that is complex and requires a certain level of knowledge on compliance, regulations, and technical and/or scientific expertise. 




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