Regulatory Approval
Posted: November 18th, 2020, 5:23 pm
Today's news about the Boeing 737 max reminds us what can happen when regulatory approval becomes a rubber-stamping exercise. First by one national authority, then others around the world recognising that as authoritative.
How will that apply with covid vaccines? We know they're desperate for Good News, so the likelihood of corners being cut might seem a priori a whole lot higher than with Boeing. Hence some questions:
How will that apply with covid vaccines? We know they're desperate for Good News, so the likelihood of corners being cut might seem a priori a whole lot higher than with Boeing. Hence some questions:
- I understand the Single Market provides a single regulatory framework for EU member states and friends, thus sparing pharma companies (and other developers of regulated products) a lot of red tape. Is that correct, and how far does EU approval go towards making a vaccine automatically legal/available in member countries?
- Does anyone know whether and how brexit affects this?
- Do we have mutual recognition - or something approaching it - of medicines with any other countries, such as the US?
- Is there routine jurisdiction-shopping by pharma companies seeking regulatory approval for a drug? If so, what jurisdictions are commonly favoured?