Discover key regulatory updates from the week of November 4th in medical devices, IVD, SaMD, pharmaceuticals, biotech, and combination products, as recognized by the Global Index powered by Hoodin. This edition highlights top regulatory news and analyses, featuring significant updates from SAPRA (South Africa) and MHRA (UK).
Global Reg Index by Hoodin
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Top Picks for November 4 - November 10
SAHPRA’s position on GLP1 and GIP-GLP1 products that are compounded, substandard and falsified Pretori SAHPRA (South Africa) Published Nov 8
AFRICA | PHARMACEUTICAL | BIOTECH | COMBINATION PRODUCTS
SUMMARY The South African Health Products Regulatory Authority (SAHPRA) has cracked down on substandard and falsified GLP-1 products, which are used in diabetes and weight management. This move highlights the importance of product integrity and supply chain vigilance, especially in emerging markets. With the growing demand for GLP-1 drugs, SAHPRA's action underscores the need for strict regulatory oversight, potentially influencing similar actions globally.
IMPLICATIONS Stricter Compliance and Supply Chain Oversight: SAHPRA’s action sets a new standard for quality control, driving long-term investments in compliance systems and supply chain vigilance in Africa.
Enhanced Consumer Confidence and Market Growth: Combating falsified products strengthens trust in legitimate pharmaceutical products, boosting patient adherence and long-term market expansion in Africa.
Global Regulatory Alignment and Increased Traceability: This initiative may prompt similar actions globally, encouraging harmonised regulations and driving demand for advanced tracking technologies to ensure drug authenticity.
Innovative Licensing and Access Pathway - Guidance MHRA (UK) | Published Nov 6
EUROPE | PHARMACEUTICAL | BIOTECH | COMBINATION PRODUCTS
SUMMARY
The MHRA’s updates to the Innovative Licensing and Access Pathway (ILAP) aim to expedite access to innovative medicines and device combinations in the UK. This streamlined process enables faster market entry, reduced costs, and potential competitive advantages for life sciences companies developing transformative therapies.
IMPLICATIONS
Faster Market Access: Expedited approval processes allow life sciences companies to bring innovative treatments to the UK market more quickly, enhancing competitive positioning.
Cost Savings: Reduced time-to-market lowers regulatory and development costs, improving profitability and allowing for faster return on investment.
Market Leadership: Accelerated access to new therapies positions companies as leaders in the industry, fostering innovation and capturing early market share.uninterrupted patient care.
* Top picks may not be the biggest news, as those updates might have already reached you. Instead, the top picks highlight the most important developments for key players in the life sciences industry that you may have missed during the week.
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