All Good manufacturing practice (GMP) articles
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Industry news
MHRA cross-agency team outlines emerging considerations for the manufacture of personalised medicines
This industry news update shares the MHRA’s guidance for the manufacture of personalised medicines.
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Journal
Deciphering the regulatory landscape of MENA markets: Challenges in pricing and ancillary issues
The pharmaceutical market in the Middle East and North Africa (MENA) region is growing rapidly, offering vast opportunities for innovation and market expansion. However, navigating the regulatory landscape in this diverse and complex region presents unique challenges that pharmaceutical companies must address in order to create a value proposition.
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Journal
Autogenous vaccines under Regulation (EU) 2019/6
Through Regulation (EU) 2019/6, it has been the first time that so-called autogenous vaccines (AVs) are included in the EU legislation that rules veterinary medicinal products. Described as inactivated vaccines which are manufactured from pathogens obtained from animals in an epidemiological unit, they are restricted to the ...