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Regulatory News

In Pharma Industry Regulation section of PharmProm.Ru we cover latest Pharma News, Pharmaceutical Industry articles, Pharma Journals, Pharmaceutical articles and more.

Regulatory News

European Pharmacopoeia to put an end to the rabbit pyrogen test

Techno -
There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected.
Regulatory News

Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis

Techno -
At this point in time, no causal relationship with myocarditis or pericarditis could be established with two other COVID-19 vaccines authorised in the EEA, COVID-19 Vaccine Janssen and Vaxzevria.
Regulatory News

The European Parliament proposed to expand the powers of the EMA

Techno -
Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies.
Regulatory News

Entry into Force of PIC/S Guidance on Good Practices for Data Management and Integrity

Techno -
The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations.
Regulatory News

WHO recommends life-saving interleukin-6 receptor blockers for COVID-19

Techno -
Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction. WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.
Regulatory News

Vector Center applies for registration of its vaccine EpiVacCorona-N

Techno -
An application for the registration of the anti-COVID vaccine EpiVacCorona-N has been submitted to the Russian Health Ministry for registration, as follows from a...
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