Quality Systems

Parth Soni is assistant manager, Development Consulting and Scientific Affairs, PharmaLex India, Noida, India.

Sebastian Joseph is principal consultant, director, Development Consulting and Scientific Affairs, PharmaLex India, Noida, India.

Articles

To restrict the use of intentionally added microplastics, the European Chemicals Agency has proposed a restriction dossier that describes various measures aimed at minimizing the use of microplastics in various industrial segments, including pharmaceuticals. In this paper, the authors discuss these restrictions.

ECHA’s Microplastics Use Restriction—Impact on Pharmaceuticals

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.

The Budding Field of Cannabis Pharmaceuticals

EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.

Coming Up to ISO IDMP Standards

Sean Milmo is a freelance writer based in Essex, UK.

The recently published European pharmaceutical strategy is being seen as an opportunity to strengthen medicines regulation in the region.

Strategizing for Strength in EU Pharma 

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

Oxford/AstraZeneca Vaccine Granted Emergency Use Approval in UK

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

CHMP Gives Positive Opinion for Pfizer-BioNTech Vaccine

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

EMA and HMA Publish Joint Strategy for Medicines Regulation to 2025

Stephanie Snow is CMC manager at Kinapse Ltd, UK.

Niamh Panesar is CMC senior manager at Kinapse Ltd, UK.

Rakesh Suman is consultant at Kinapse Ltd, India.

Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

Nitrosamine Impurities in Medicinal Products

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future. 

Inspecting GMP at a Distance

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

Regulatory/GMP Compliance, Europe