EU asks industry to comment on non-EU pharma company controls

Published: 19-Dec-2011
Regulatory

Also asking industry to assess checklist of standards


The European Union (EU) pharmaceutical industry has been asked how closely non-EU countries need to work with EU medicine safety controls to access member country markets.

In a formal consultation, the European Commission is asking whether exporting countries should participate in the EU’s pharmaceutical ‘Community information and rapid alert system’, and/or directly alert the EU of any local suspension or withdrawal of a medicine’s marketing authorisation.

The EU is also asking pharma companies to assess a checklist of standards that non-EU medicine inspection agencies need to follow, if their countries are allowed to sell pharmaceuticals to the EU.

The consultation – which ends on 23 March – has been sparked by the agreement of EU directive 2011/62/EU ‘relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products’. It says active substances shall only be imported accompanied by written confirmation of good manufacturing practice from a competent authority.

See more

You may also like

Regulatory

Overcoming CMC challenges in cell and gene therapy: part II

Read more
Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs

Trending Articles

  1. Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
  2. Overcoming CMC challenges in cell and gene therapy: part I Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  3. Overcoming CMC challenges in cell and gene therapy: part II Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  4. The rising importance of preservative efficacy testing When considering the regulation and validation of pharmaceutical products, the efficacy of the active pharmaceutical ingredient (API) is often the main concern
  5. The right validation model: practical considerations and applications It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow and how to navigate through them in the real world. Hurdles to overcome include the specific deliverables that make up that model and how they change during the various interactions along the validation journey

Upcoming event

Cleanroom Conference UK

22–23 May 2024 | Exhibition | Birmingham, UK See all

You may also like

Regulatory

Overcoming CMC challenges in cell and gene therapy: part II

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
Regulatory

Overcoming CMC challenges in cell and gene therapy: part I

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
Regulatory

AskBio receives FDA Fast Track Designation for congestive heart failure gene therapy programme

The fast-tracking allows the development and expedition of review processes for AB-1002, a gene therapy to promote production of a constituently active form of I-1c
Manufacturing

Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success

Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
Regulatory

Isospec Analytics launches biomolecular analysis technology to identify unknown molecules

The novel technology optimises the identification process of unknown molecules compared to mass analysis
Regulatory

4SC AG receives Paediatric Investigation Plan waiver for resminostat from the UK MHRA

The waiver allows the company to avoid investigating the CTCL drug in a paediatric population, as it's considered unnecessary or inappropriate for use by this patient group
Regulatory

The key role of IVDs in healthcare: challenges to commercialisation and access

In simple terms, in vitro diagnostic (IVD) tests are done on samples such as blood or tissue that have been taken from the human body. IVDs can detect diseases, conditions and infections, provide patients with a better understanding of their ailment and how it might be managed and changed with treatment
Subscribe now