The European Medicines Agency recently launched a public consultation on a draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.

Read the EIPG Feedback on the draft guideline.

The European Industrial Pharmacists Group is preparing comments on two more documents submitted for consultation by the European Medicines Agency.

The first document is “Scientific guideline: Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009), draft: consultation open“. This addendum to the guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009) intends to provide clear definitions of terms used for metabolic phenotyping, as well to propose concepts regarding the translation of genotypes into the predicted metabolic phenotype, of significant importance for the correct treatment of patients. The EMA consultation deadline is the 10th October, 2017. Comments can be submitted before the 5th October to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

The second document is “Scientific guideline: Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development, draft: consultation open“. The reflection paper provides current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development. It raises open issues from a methodological perspective addressing questions related to comparison objectives, sampling strategies, sources of variability, acceptance ranges and statistical analysis approaches to conclude on the similarity of two drug products based on quality attribute data. A main objective of the reflection paper is to establish a framework and a common language to facilitate future discussion among stakeholders and to invite comments in relation to the issues raised. The EMA consultation deadline is the 31st March, 2018. Comments can be submitted before the 1st December to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

The European Medicines Agency have published: Scientific guideline: Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol, draft: consultation open.

This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorised in the Europe Union / European Economic Area. It aims to provide advice on what should and what should not be classified as a serious breach and what must be reported. It does not include guidance related to urgent safety measures or other reporting obligations related to subject safety. More information is available on the EMA’s website.

The EMA consultation deadline is the 22nd August, 2017. Comments can be submitted before the 18th August to the contact persons of the EIPG Member Associations, or directly to the EIPG Vice-President Technical and Professional Development, Piero Iamartino.

The European Industrial Pharmacists Group (EIPG) notes with satisfaction the latest figures issued by Eurostat in regards of international trade by Member States of the European Union in medicinal and pharmaceutical products. The figures point to the pharmaceutical industry, in the area of export of medicinal products, as a key contributor to the economy of the European Union, leading other global areas in the sector. This success is due, in no small manner, to the role of professionals operating within the sector, in particular the industrial pharmacist. EIPG therefore takes this opportunity to highlight the importance of the industrial pharmacist as a key professional within the European pharmaceutical industry, and to solicit the importance of ensuring that industrial pharmacy remains a key component of pharmacy curricula throughout Europe, as well as to ensure that suitable opportunities continue to be made available for pharmacy students and graduates choosing this career path.

EIPG also notes that that the importation activity of medicinal and pharmaceutical products within the European Union is second only to that of the United States. This highlights the importance of the various measures within the Falsified Medicines Directive that have the objective of preventing falsified medicinal products from reaching patients in Europe. Here, again, industrial pharmacists are individuals whose role in the setting up of a European medicines verification system throughout the pharmaceutical supply chain must not be underestimated. EIPG, therefore, reiterates its opinion that the presence of professional associations representing industrial pharmacists within organisations responsible for the implementation of the system is important to ensure its success.

The European Industrial Pharmacists Group (EIPG) is a European association representing the national, professional organizations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines.

A second summer Training School on “Medicines Shortages” (COST Action CA15105 – European Medicines Shortages Research Network – addressing supply problems to patients) addressing Pharmaceutical Supply Chains II is being organized by the Instituto Politécnico de Portalegre (IPP) and Centro de Recursos Naturais e Ambiente (CERENA/IST), with the support of IBM Portugal and TAP Portugal. The programme stakeholder and local organiser is Prof. Joao Luis Miranda. Teachers, researchers, MSc/PhD students, post-docs, and practitioners will meet at the College of Technology and Management (ESTG/IPP), Portalegre, Portugal, 03-07 of July-2017, to discuss “Medicines Shortages” topics.

The program consists of a seminar that is open to the general public on the first day (3rd July). The seminar will present other relevant challenges to the Action, and the participants in the seminar will also gaining a complete overview of the Training School, since the main topics of the technical sessions in the following days will also be introduced.

Attendance at all five days of the school is strongly recommended for those participants interested in Medicines Shortages and in the Pharmaceutical Supply Chain. However, attending either the seminar, the workshops, or only one of the technical sessions is possible upon registration.

Beyond the active participation in the technical sessions, young researchers are also invited to present their works related to the Action subjects and to Pharmaceutical Supply Chain, either by Poster or in a special session for oral presentations.

A Registration Form is available online.

Additional information about the Speakers, Program or other topics of interest is available on the event website or by contacting the Portuguese Coordinator directly.

The European Commission recently launched a targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the European Commission.

Read the EIPG Feedback on the targeted stakeholder consultation.

The European Medicines Agency recently launched a public consultation on draft Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012). EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.

Read the EIPG Feedback on the draft questions and answers.

The European Commission has launched a targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use.

According to Article 63(e) of Directive 2001/83/EC the Commission, in consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated. The original Guidelines on excipients in the labelling and package leaflet of medicinal products for human use were adopted in 2003. These regulatory guidelines are part of Volume 2C of the Notice to Applicants. An amended version of the Guidelines have been prepared in order to reflect the development since publication of the original version. Opinions of the targeted stakeholders on this amended version are being sought. More information is available on the Commission’s website, where the consultation document can also be found.

Comments can be submitted by the 1st May to the contact persons of the EIPG Member Associations.

A Training School on “Medicines Shortages” (COST Action CA15105) addressing Pharmaceutical Supply Chains (SC) is being organized by the Instituto Politécnico de Portalegre (IPP). The programme stakeholder and local organiser is Prof. Joao Luis Miranda. Teachers, researchers, MSc/PhD students and practitioners will meet at Instituto Superior Técnico (IST), Lisboa, Portugal, between the 26th and 28th of April 2017, to discuss topics relevant to the Pharmaceutical Supply Chain within the COST Action “Medicines Shortages” (CA15105), European Medicines Shortages Research Network – addressing supply problems to patients.

The program consists of a seminar that is open to the general public on the first day. The seminar will introduce the Action, its main goals, methodology and workplan; the participants in the seminar will also gain a complete overview of the Training School, since the main topics of the technical sessions in the following days will also be presented.

Attendance of all three days of the school is strongly recommended for those participants interested in Medicines Shortages and in the Pharmaceutical Supply Chain. However, attending either the seminar, the workshop, or only one of the technical sessions is possible upon registration.

A Registration Form is available online. The deadline for registration was originally the 26th February, but has now been extended to Sunday 5th March.

Additional information about the Speakers, Program or other topics of interest is available on the event website or by contacting the Portuguese Coordinator directly.

The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages.

Focusing on the transparency and the availability of medicine shortage data, the Associations’ statement is part of their wider commitment to tackling the issue. Evidence suggests it is an increasing problem across the European Union, having a significant impact on patients, on health professionals, on healthcare systems and suppliers.

The recommendations call for greater transparency and availability of medicines shortage data, early detection and assessment of potential shortages, consistency of reporting, increased access to the information available across all parts of the supply chain, improved data infrastructure, and collaborative governance processes.

The recommendations aim to mitigate the impact of shortages on patients, provide patients and health professionals with up-to-date, meaningful information and improve the ability of health systems to diagnose and solve supply issues as they arise.

This statement builds on existing good practices and recommends some specific features of ideal medicines shortages information systems. The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists hope that, taking into consideration the national specificities of each country, these recommendations can help enhance information systems at a national level, and potentially form the basis of future European level action.

  Joint Supply Chain Actors Statement on Information and Medicinal Products Shortages