Donate to Remove ads

Got a credit card? use our Credit Card & Finance Calculators

Thanks to Wasron,jfgw,Rhyd6,eyeball08,Wondergirly, for Donating to support the site

Regulatory Approval

Straight answers to factual questions
Forum rules
Direct questions and answers, this room is not for general discussion please
UncleEbenezer
The full Lemon
Posts: 10814
Joined: November 4th, 2016, 8:17 pm
Has thanked: 1471 times
Been thanked: 3005 times

Regulatory Approval

#357853

Postby UncleEbenezer » 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:

  1. 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?
  2. Does anyone know whether and how brexit affects this?
  3. Do we have mutual recognition - or something approaching it - of medicines with any other countries, such as the US?
  4. Is there routine jurisdiction-shopping by pharma companies seeking regulatory approval for a drug? If so, what jurisdictions are commonly favoured?

johnhemming
Lemon Quarter
Posts: 3858
Joined: November 8th, 2016, 7:13 pm
Has thanked: 9 times
Been thanked: 609 times

Re: Regulatory Approval

#357866

Postby johnhemming » November 18th, 2020, 5:46 pm

I think our membership of the single market will come to an end before any vaccine is fully available. Noone yet knows how brexit will affect the issue of medical regulation.


Return to “Does anyone know?”

Who is online

Users browsing this forum: No registered users and 27 guests