As communicated by EMA:

“The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).

From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).

It is therefore necessary that all organisations currently regulated through EudraGMDP (which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances) are registered in OMS.”

The development of the database – the Manufacturers and Wholesale Distributors database (MWD) – started on 1 July 2021 and is currently in its test phase.

What is the Organisation Management Service (OMS)?

As per EMA the “OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes.

It stores master data comprising organisation name and location address for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. “

OMS has published a Data Quality Standard and integrating EudraGMDP with OMS should ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP.

What does this mean for access to public data in EudraGMDP?

Our understanding is that “access will continue as before – no changes are foreseen”.  

Webinar

The EMA will organise a webinar on the OMS services for interested manufacturers, importers and distributors on 12 October 2021 at 14:00 – 16:30 CEST. Participants will have the chance to ask questions and seek clarifications on OMS services and activities.

The US Pharmacopeia is proposing a new informational chapter on Supplier Qualification – <1083>. This was previously published as a chapter on good distribution practices and now <1083> is repurposed to focus on a risk-based approach to Supplier Qualifications.

The initiative has its roots in a white paper  “Good Supply Practices for the 21st Century”, published by Xavier Health in 2018 and will discuss the importance of supplier qualification and the application of a quality risk-based approach. 

The chapter outlines examples of supplier types that should be qualified, a six-step process of Supplier Qualification Life Cycle Management along with points to be considered in a risk assessment broken down by risk category.

While the USP general chapters numbered <999> and above are general guidelines rather than being enforceable by law, <1083> contains some good indications on the use of risk-based supplier qualifications. Commenting on <1083> is open until 30 November 2021.

“Amid the rise in counterfeiting and other illegal activities related to the Covid-19 pandemic, the Council of Europe is issuing new recommendations to governments based on its Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention).

As regulators around the world approve more vaccines for sale, reports of seizures of counterfeit vaccines continue to rise.

In an opinion published today, the MEDICRIME Committee sets out 13 measures to prevent and combat the presence of counterfeit vaccines on the market, including vaccines that misrepresent their identity and/or source, as well as the diversion of legally produced vaccines from the legal supply chain.

The Committee proposes preventive measures in co-operation with the relevant sectors to strengthen the supply chain, ensure the authenticity of vaccines, and improve arrangements for the disposal of Covid-19 vaccine waste.

The Committee also emphasises the importance of training relevant government officials (customs officers, police and judges) and raising public awareness.

Background

The only international treaty of its kind, the 2011 Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention) has been ratified by 18 countries and signed by 15 others in Europe and beyond.

The Convention provides a framework for national and international co-operation between the competent health, police and customs authorities at both national and international level, measures for crime prevention by also involving the private sector, and the effective prosecution of crime and the protection of victims and witnesses.

In 2020, the MEDICRIME Committee published an opinion on the application of the Convention in the context of Covid-19.“

In light of the COVID-19 pandemic, too low levels of adopting a digital strategy in the pharmaceutical industry and the prevalence of paper-based processes in the validation of applications and processes , GAMP Francophone, has published a position paper on US-FDA’s initiative on CSA – Computer Software Assurance. The CSA is a prioritized guidance document, intended to be published in FY2021by the FDA. The new guidance is intended to shift the focus of the document-oriented computer validation towards a risk-based, critical thinking approach.

The position paper observes that the practices in the healthcare industry “show a certain difficulty, or even inability, to take advantage of technological developments and alternative project management approaches”

The paper stresses the importance of not immobilizing the technical and digital evolution while waiting for FDA’s new guidance document on CSA– but meticulously plan for the anticipated progress and take the opportunity to invest in the understanding of new technologies. It also underlines that the current European regulatory framework “through its systematic consideration of quality risk management”, currently do provide generous amplitude for implementing new and innovative approaches and that GAMP5 in a similar manner encourages creativity and efficiency in their industry practices.

As a company developing digitized compliance solutions to the pharmaceutical industry which will be validated, we are certainly looking forward to the published guidelines.