Category Archives: 2018

An Upcoming EMA Public Hearing on the Safety of Quinolone and Fluoroquinolone Antibiotics

On 11th April 2018 the Pharmaceutical Journal (Vol 300, No 7912, p 201) reported that the European Medicines Agency (EMA) is to hold a public hearing on the safety of quinolone and fluoroquinolone antibiotics, as part of an ongoing Pharmacovigilance Risk Assessment Committee (PRAC) review of these medicines.

As the above chemical names might suggest, the main distinction between these two classes of compound is that the fluoroquinolone compounds contain a fluorine atom, attached to the all-carbon ring in these heterocyclic molecules, and compounds in quinolone group do not.

Concern has been growing about serious long-lasting side effects in patients after taking a quinolone or a fluoroquinolone antibiotic especially for mild infections.

The date of the hearing has been set for 13 June 2018 and the Agency has invited applications to attend from patients, researchers and health professionals — including pharmacists. Hopefully some carers have been included too, a group often overlooked.

Keep your eyes open for the findings of the hearing, which we will try to report on when the outcome is available. Will both classes of compound be of equal concern or not?

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More than a Generation of Husbanding Scarce Professional Resources

The PHARMACEUTICAL INSPECTION CONVENTION (PIC) was formed in 1970 by the 10 countries that at the time comprised the European Free Trade Association (EFTA). Some of those countries have since left the PIC and others have joined.

The initial objectives included harmonisation of Good Manufacturing Requirements (GMP) and Mutual Recognition of Inspections carried out by Inspectors from PIC countries. With the explosive worldwide growth of pharmaceutical manufacturing and related activities it was recognised that were not enough experienced Inspectors to cope with the expanding workload of inspections and associated activities.

Legal and other reasons prevented certain other countries from joining the PIC and in 1995 the PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) was formed. Essentially and, one might say, cleverly, PIC and PIC/S operate jointly thereby allowing a larger group of countries to task inspectors with participating in inspections. The findings are shared as and when needed and are mutually recognised by all member countries (currently 51 as at 15 May 2018).

A PIC/S Committee and PIC/S Executive Bureau meeting took place in Geneva, Switzerland on 15-18 April 2018 and minutes of the meeting were published on 9 May 2018.

Headlines are:

  • NEW PIC/S GUIDANCE ON GMP INSPECTION RELIANCE BASED ON DRAFT BY ICMRA WITH AIM TO MAXIMISE INSPECTION RESOURCES FOR GMP COMPLIANCE OF OVERSEAS FACILITIES

  • REVISION OF PIC/S GMP GUIDE (PE 009). CHAPTERS 3, 5 AND 8 OF THE PIC/S GMP GUIDE HAVE BEEN REVISED AND WILL ENTER INTO FORCE ON 1 JULY 2018; ALONG WITH ADOPTION OF TRANSPOSITION FOR PIC/S PURPOSES OF EU GUIDANCES ON GMP EXICIPENT RISK ASSESSMENT, EXPOSURE LIMITS AND GDP FOR API

  • NEW PIC/S WORKING GROUP ESTABLISHED WITH W.H.O. TO REVISE ANNEX 2 ON BIOLOGICALS AND ATMP

  • FOCUSED STAKEHOLDER CONSULTATION FOR DRAFT PIC/S GUIDANCE ON DATA INTEGRITY

  • NEW PIC/S AIDE-MEMOIRE ON CROSS-CONTAMINATION IN SHARED FACILITIES

  • NEW PIC/S PRE-ACCESSION APPLICATION RECEIVED FROM PAKISTAN / DRAP

  • NEW PIC/S WORKING GROUPS TO BE ESTABLISHED ON WHISTLE-BLOWERS/CONFIDENTIAL INFORMANTS; QUALITY DEFECTS PROCEDURES; AS WELL AS PIC/S ASSESSMENT AND RE-ASSESSMENT PROCEDURES

  • PIC/S 2018 SEMINAR TO BE HOSTED BY US FDA IN CHICAGO AND OTHER NEWS IN THE FIELD OF TRAINING FOR GM(D)P INSPECTORS

ICMRA = International Coalition of Medicines Regulatory Authorities

GMP = Good Manufacturing Practices

API = Active Pharmaceutical Ingredient

W.H.O. = World Health Organisation

ATMP = Advanced Therapy Medicinal Products

DRAP = Drug Regulatory Authority of Pakistan

GM(D)P = Good Manufacturing (Distribution) Practices

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regulatory intelligence

Our Current Objectives

Good regulatory practice and individual professional codes require staff working in pharmaceutical regulatory affairs to be trained appropriately and to maintain their professional competences [Continuing Professional Development (CPD)].

Through our regulatory consultancy and training businesses Pharmaceutical Quality Matters and PharmaQMtraining.eu, we can provide regulatory expertise and training on pharmaceutical subjects concerning drug substances (active substances) from their discovery onwards until they become drug products (finished medicinal products/dosage forms). If an active substance is new the regulatory demands can be huge whereas if it is a known or ‘existing’ drug substance the regulatory burden will usually be much lighter unless a new method of administration or a novel formulation is involved.

Complex regulatory procedures have to be followed and satisfied before a clinical trial can begin and there are even more extensive requirements to be met in order to gain approval of an application for a Marketing Authorisation (MA) (also known as a Product Licence, particularly in the UK) to allow a specified product to be sold or supplied to patients.

In all cases the industrial Intention of medicines’ development is to produce a safe and effective product but the story does not end with the granting of a MA. Adverse events have to be monitored, this being part of the major effort put into the regulatory topic of Pharmacovigilance.

For each particular approved medicine there is also the need for life-cycle management to keep any given product up to the required quality, safety and efficacy standards whilst recognising that commercial considerations and maintenance of supply may also be key factors.

In this site’s Blog Posts and also through the LinkedIn group Pharmaceutical Regulatory Training we will try to focus our writings on regulatory intelligence impacting on medicines’ development with a focus on new legislation and new guidelines and other relevant guidance from ICH and various national/multinational bodies in order to see how and where these may have an impact on the licensing and life-cycle management of new medicines. Contributions and analytical comments from readers will be welcomed especially where they enhance the training potential offered by these activities.

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Interesting times – new series of posts coming to help you

Many of you who visit this Blog because you have an interest in Pharmaceutical Regulatory Affairs may think we live in challenging and possibly interesting times. Certainly Brexit has serious potential to muddy the relatively clear waters in which we have been navigating in our careers whilst in the EU.

Soon, some things are bound to change but so far, apart from knowing that the European Medicines Agency is being relocated from London to Amsterdam, little clarity is close to hand.

Pharmaqmtraining.eu, which might even have to contemplate its own name change although we hope not, will endeavour to continue providing you with useful insight to help you in your regulatory careers.

Going forward we propose to help you with useful and regular commentary on changes to pharmaceutical regulatory subjects and practices. Keep an eye open for our communications from whatever channels we can legally use. Such methods will include messages to you if

  1. you are signed up to the Pharmaceutical Regulatory Training group on LinkedIn, or
  2. if you have ‘signed up’ on the PharmaQMtraining.eu mailing list in line with the soon to be compulsory GDPR in full to receive messages from us. You can do this by completing the Opt-In form 

For those of us who maintain interests in pharmaceutical activities predominantly in the United Kingdom we may be exposed to more changes than others who might need only to understand what affects EU countries. Either way, stay in touch with us please and we will do our best to keep you informed with helpful news.

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