US FDA is now aware of 414 cases of breast implant-associated anaplastic large cell lymphoma. The agency says that updated medical literature estimates of the lifetime risk of textured breast implanted patients developing BIA-ALCL range between 1 in 3,817 to 1 in 30,000.

The European Court of Justice judgment on the TÜV Rheinland notified-body liability case raises more questions than answers. In particular, there is uncertainty over its impact on the need for notified bodies to perform unannounced audits.

UK preparations for a Brexit deal with the EU are not following the smooth path that the UK government would like, as more and more complications emerge. The executive bodies charged with translating Brexit seamlessly into UK policy and law can only watch and wait, but the MHRA, for one, has a strong feel for what is best for UK health care stakeholders.

The Emerging Markets Regulatory Tracker is a periodic PharmAsia News feature that summarizes and links to important regulatory developments impacting the biopharma and medical device industries in the Asia Pacific region and other emerging markets.