Author: Dan Paul Andreianu

Data Integrity Webinar

On Tuesday 22 September 2020 PQG organised a Data Integrity Webinar with Dale Carter, Head of Quality – Evonik Corporation. 

In this presentation, Dale reviewed the recently released position paper on Data Integrity for Pharmaceutical Grade Excipients published by the International Pharmaceutical Excipients Council Federation (IPEC).

The paper was developed to supplement published Regulatory guidance defining Data Integrity requirements for drug substances and medicinal products, some of which are not easily adaptable to the manufacture of excipients.

The presentation (supporting slides available here) covered Data Integrity principles, Regulatory guidance documents and recommendations on how to apply Data Integrity to excipient manufacturing and distribution.

Week 36 – News

Just in case you missed some of this week’s news, here are the highlights:

  • MHRA published on 1 September 2020 guidance for industry and organisations to follow after the end of the transition period.

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

Stakeholders need to get ready for new rules from 1 January 2021.

This guidance covers the following topics:

  1. Clinical trials
  2. Devices
  3. Licensing
  4. Importing and exporting (for those of you who read the previous post on PQG this is old news already)
  5. IT systems
  6. Pharmacovigilance (updated today with the new guidance ‘Guidance on QPPV including PSMFs)
  7. Paediatrics

 

  • EMA has published today the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August – 3 September 2020.

 

  • For those who chose to work late on a Friday, there is still time to provide feedback as part of the public consultation launched by EMA on joint network strategy to 2025. Use this link to access the questionnaire.

The draft strategy details how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

It outlines six priority areas for the network:

  • the availability and accessibility of medicines;
  • data analytics, digital tools and digital transformation;
  • innovation;
  • antimicrobial resistance and other emerging health threats;
  • supply chain challenges; and
  • the sustainability of the network and operational excellence.

 

 

 

EU Exit – Acting as a RPi – Responsible Person (import) from 1 January 2021

From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’.

The guidance published on 1 September 2020 describes how you can apply to be a RPi, and how to verify that QP certification of a medicine has been done in the EEA.

The registration scheme for RPi candidates will be applicable from 1 January 2021 and RPi applications may be submitted through the MHRA Portal after this date.

The Responsible Person (import) (RPi) is described in regulations 45AA and 45AB of the Human Medicines Regulations 2012 (as amended) and is responsible for implementing a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain (England, Wales and Scotland) from countries on an approved country for import list (initially, this will be countries in the EEA).

In scope

  • A UK or Great Britain licensed medicine for use in Great Britain
  • A UK or Great Britain licensed medicine for supply to another third country
  • A Northern Ireland or approved country licensed medicine for supply to fulfil special clinical needs
  • A Northern Ireland or approved country licensed medicine imported as an introduced medicine for supply to another third country
  • A Northern Ireland or approved country licensed medicine for use as a parallel import

Out of scope

There will products which will not require RPi oversight such as medicinal products sourced from Northern Ireland. For wholesale purposes they are out of scope of this guidance and this is permitted under the supervision of a Responsible Person (RP).

Products with a UK or Great Britain marketing authorisation that are imported into Great Britain from outside the UK  without QP certification from a country on the list will require QP certification under a UK manufacturing and import authorisation before being placed on the market.

Products without a marketing authorisation in the UK, Northern Ireland, Great Britain or a listed country are outside the scope of this guidance. Importation of such products is permitted under the supervision of a Responsible Person (RP), with notification to the MHRA of each importation that is for supply to the Great Britain market.