Industry News

Serialisation: A New Guidance for EU Inspectors


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 [...]

Serialisation: A New Guidance for EU Inspectors2019-07-04T10:46:36+01:00

EMA’s quality guideline for drug device combinations


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 [...]

EMA’s quality guideline for drug device combinations2019-07-01T13:47:50+01:00

MIAS Pharma Ltd Services Overview


MIAS Pharma Limited, your European Partner, provides contract QP services to enable you to import and QP Release human medicinal products into Europe in a compliant manner. Watch our CEO, Ann McGee, provide a high-level overview of our service offering. If you would like to get in touch [...]

MIAS Pharma Ltd Services Overview2019-06-13T13:26:00+01:00

EU – FDA MRA has approved two more countries


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 [...]

EU – FDA MRA has approved two more countries2019-05-29T10:39:17+01:00

Working together for safe medicines in the EU


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 [...]

Working together for safe medicines in the EU2019-05-22T13:37:36+01:00

EMA’s Annual Report on the EudraVigilance Database


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). [...]

EMA’s Annual Report on the EudraVigilance Database2019-04-26T10:28:07+01:00

The MRA between the EU & US


In March 2017, it was a historical month, not just for pharmaceutical industry but for the United States of America and the European Union. The amended mutual recognition agreement (MRA) on “Pharmaceutical Good Manufacturing Practices” between the EU and the US was signed. The best outcome is that it could significantly reduce [...]

The MRA between the EU & US2019-04-19T11:07:41+01:00

EU urged to safeguard post-Brexit medical supplies from the UK


EU member-states have been urged to do more to safeguard the supply of medicines post-Brexit by European pharmaceutical leaders. The European Federation of Pharmaceutical Industries and Associations called on European leaders to allow medicines and medical devices quality which is tested in the United Kingdom, to be recognised in the European Union. [...]

EU urged to safeguard post-Brexit medical supplies from the UK2019-03-20T14:20:44+01:00

Brexit: The EU supports pharmaceutical Companies


When medicinal products are imported into the EU, they must undergo batch testing within the European Economic Area (EEA). Once the United Kingdom leave the EU due to Brexit, it has the following effects on the Pharmaceutical industry. Pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate [...]

Brexit: The EU supports pharmaceutical Companies2019-03-06T14:15:26+01:00

100 jobs announced at pharmacetuical services firm


IQVIA, the US firm that provides support services in the pharmaceutical, biotech and medical sectors have announced 100 new jobs in Dublin. They have begun recruiting in areas of clinical project management, data management and biostatistics. IQVIA stated how they are seeking pharmacovigilance specialists also. The company expect the jobs to be [...]

100 jobs announced at pharmacetuical services firm2019-02-22T11:26:17+01:00

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