15 08, 2019

What is considered GMP-compliant equipment design?

By |2019-08-15T10:11:08+00:00August 15th, 2019|General News|

A question that gets frequently asked is what GMP-compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products / APIs. The short answer is: the system must be qualifiable. Since this require some clarification, here

11 07, 2019

New Regulatory Approach for Cannabis Products!

By |2022-10-18T15:30:42+00:00July 11th, 2019|General News|

Health Canada has proposed a regulatory pathway for a new class of cannabis products known as Cannabis Health Products (CHPs). On June 19, 2019, Health Canada started a consultation on potential market for CHPs that would not require a practitioner’s oversight. Health Canada are accepting comments until September 3, 2019. There is

4 07, 2019

Serialisation: New Guidance for EU Inspectors

By |2022-10-25T16:07:59+00:00July 4th, 2019|Industry News|

In 2011, the European Commission (EC) published Directive 2011/62/EC, the Falsified Medicines Directive (FMD). The main objective was to support the fight against counterfeit medicines. The new Directive had a big influence on the pharmaceutical supply chain. It introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had

1 07, 2019

EMA’s quality guideline for drug device combinations

By |2019-07-01T13:47:50+00:00July 1st, 2019|Industry News|

The European Medicines Agency (EMA) have released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation. This guideline provides guidance on the documentation expected for Drug-Device Combinations in the quality part of the dossier

27 06, 2019

Medicinal cannabis now being made available under a pilot programme

By |2019-06-27T12:07:36+00:00June 27th, 2019|General News|

Medicinal cannabis is being made available under a pilot programme. The pilot programme which allows access to cannabis-based products for medical use has been launched by the Minister for Health, Simon Harris. Legislation giving the go ahead for the Medical Cannabis Access Programme to operate in Ireland was signed yesterday by Simon

13 06, 2019

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands

By |2019-06-13T13:24:29+00:00June 13th, 2019|General News|

The European Medicines Agency (EMA) announced on Tuesday that Luxembourg and The Netherlands have now joined the mutual recognition agreement for Good Manufacturing Practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states. This announcement comes six months after Cyprus and Bulgaria joined the agreement. The MRA,

24 05, 2019

EU – FDA MRA has approved two more countries

By |2019-05-24T13:32:15+00:00May 24th, 2019|Industry News|

With the Mutual Recognition Agreement (MRA) between Europe and the USA, inspections are to be mutually recognised in the future. The Food & Drug Association (FDA) approval of EU member states continue to proceed successively. Two more countries have recently been approved, they are Bulgaria and Cyprus. That means there is now

8 05, 2019

Working together for safe medicines in the EU

By |2019-05-08T12:40:46+00:00May 8th, 2019|Industry News|

The European Medicines Agency (EMA) protects patients to ensure they are safe. The EMA accesses, supervises and monitor medicines before they can appear in hospitals and pharmacies. The agency monitors information on side effects reports from doctors, pharmacists, patients, new clinical studies and new scientific publications. This data will be reviewed by

26 04, 2019

EMA’s Report on the EudraVigilance Database

By |2022-10-26T09:32:56+00:00April 26th, 2019|Industry News|

The EudraVigilance database is used for the Europe-wide registration and analysis of adverse reactions to medicinal products authorized within the EU. EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).

Go to Top