Regulations keep us safe; the manufacture of API in the UK is very tightly regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), which ensures that API made in the UK meets quality standards.
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Such rules are necessary to protect the consumer, but they also hinder the rate of innovation. The various players in the industry must always walk a fine line between conformity with these rules and creativity. As a result, most firms shy away from experimentation, as they are not willing to risk offending – or finding themselves punished by – the jurisdiction’s agencies.
Nevertheless, the collaboration between regulator and industry leader seems to be working. Dialogues are ongoing, processes are being streamlined, and safety will continue to be maintained, so new ways of kiting the rules can be allowed in the spirit of innovation.
Future Trends in Hi-tech API Development
The hi-tech API manufacturing industry has a bright future ahead of it in the UK. There is a growing trend of personalised medicine where treatments are prepared based on the patient’s individual profile and specific aspects like genetic factors.
This way of thinking will require reconsideration of production itself – less ‘one size fits all’ – and might see the spread of technologies such as 3D printing and bioprinting, which have heretofore been regarded as niche, reaching the mainstream with unprecedented flexibility of production.
Furthermore, the theme of sustainability will be key. As UK API manufacturers navigate the changing landscape, they will progress to ‘greener’ manufacturing processes that minimise wastage and energy consumption. The use of renewable energy sources and sustainable materials will be pivotal to help these manufacturers in becoming not only more competitive in the market but also help widen positive outcomes towards a world in transformation.