Press Room

News / Feb 26, 2021

Guy Villax spoke for the EU API industry

Today, at the EU Pharma Strategy Structured Dialogue

Guy Villax EFCG European Commission

Guy Villax spoke for the EU API industry at the EU Pharma Strategy Structured Dialogue that the EU Commission launched today. He said:

EFCG members make Active Pharmaceutical Ingredients, the core of medicines.

The EU has not been in control over its generic medicines for some time – we face frequent shortages and a geostrategic fundamental dependence on APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.  

We have ended up in this untenable situation due to i) unbridled market forces and globalization and ii) 30 years of EU regulations that did not consider that pharma is an intensely globalized and highly competitive industry. 

Europe was once the cradle of pharmaceuticals. Today price pressure has driven the generics supply chain to prefer to buy 74% of APIs and precursors from low cost countries with limited regulation. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – EU industry cannot compete with such low cost operations.  

EFCG was founded to level the playing field, this need remains. An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field.

The US and Japan have already launched countermeasures, we must work with our allies and not independently.

European citizens deserve medicines that are Affordable, Accessible and most importantly Available. EFCG knows the issues well and is ready to help, count on us in this partnership. Pierre Luzeau will next list the needed solutions.

 

 

The meeting gathered representatives of pharma industry (generics and innovators), patients, hospital pharmacists as well as addressed Minister Marta Temido, MEPs Dolors Montserrat and Nathalie Colin–Oesterlé, Commissaires Kyriakides and Breton, Vice President Schinas. 

 

About the Structured dialogue on Security of Medicines Supply  

About EFCG

 

 

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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