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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

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...
Expert Articles

Latest patent reforms to further bolster innovative pharma research in China

Techno -
According to GlobalData’s Pharma Intelligence Center Chinese patent authority is ranked on the top with 16,983 pharmaceutical grants issued so far in H1 2021.
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