EU Focus Archives - European Industrial Pharmacists Group (EIPG)

The Pact for Research and Innovation in Europe


by Giuliana Miglierini The roadmap to support the implementation of the new vision of the European Research Area (ERA) made a concrete step forward on 16 July 2021, with the adoption by the European Commission of the proposal for a Read more

The opportunity for repurposing of oncology medicines


by Giuliana Miglierini Rare cancers, which account for approx. 22% of new cases in Europe, represent an area of low business interest for the pharmaceutical industry, due to the limited number of patients compared to the very high costs to Read more

A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry


by Giuliana Miglierini Less than a year has gone since the Brexit, and the UK innovation landscape is experiencing a new, vivid era of expansion under the stimulus of a strong demand from global investors. According to recent data of Read more

Draft guidelines, open for consultation

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ICH guideline Q13 on continuous manufacturing of drug substances and drug products

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.
It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.

Consultation dates: 29/07/2021 to 20/12/2021
Open Consultation file (Click here)


Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.

This guideline describes the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells. This applies to allogeneic or autologous, including viral vector modified and genome edited cells.

Consultation dates: 30/07/2021 to 31/10/2021
Open Consultation file (Click here)


EMA publishes Q&A Document about Parallel Distribution

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The European Medicines Agency (EMA) has published a new document entitled “Frequently asked questions about parallel distribution” (EMA/297155/2021). The 30-page PDF file contains answers to the most common questions. It is divided into the following sections:

  • General information
  • Initial notification
  • Parallel distribution notification check
  • Post – Parallel distribution notice guidance
  • Safety Updates / bulk changes / annual update
  • Fees

The document is clearly laid out and contains a number of internal references as well as links to Directives, Guidances and other references. The PDF is available on the EMA homepage under “Frequently asked questions about parallel disctribution“. The questions are also listed on the EMA Website.

Furthermore, the EMA has updated the following three documents on parallel distribution:

  • “List of centrally authorised products requiring a notification of a change for update of annexes” (EMA/278602/2021)
  • “Checklist for initial notifications for parallel distribution: guidance for industry” (EMA/267299/2020 Rev. 1)
  • “Checklist for annual updates for parallel distribution: guidance for industry (EMA/405782/2020 Rev.1)

All documents are available on the EMA website in the section “Parallel distribution: Regulatory and procedural guidance“.