Industry News

Pharma giant tackling counterfeit drugs using blockchain

2019-09-19T12:02:36+01:00

Fighting counterfeit drugs with blockchain technology… The Asia-Pacific pharmaceutical giant Zuellig pharma is using a blockchain platform by SAP to assist consumers identify the medicines place of origin. With 1 in 10 medicinal products that are used in developing countries deemed fake, there is a substantial need to eradicate counterfeit drugs that [...]

Pharma giant tackling counterfeit drugs using blockchain2019-09-19T12:02:36+01:00

Brexit Preparedness Checklist – HPRA

2019-09-17T13:44:34+01:00

The Health Products Regulatory Authority (HPRA) have released a 'Brexit Preparedness' checklist. The checklist has been divided into four parts which include:  Supply Chain  Customs  Medicines Regulatory Compliance Medical Devices Supply Chain In relation to the supply of medicines and medical devices, companies are requested to: Map your supply chain to [...]

Brexit Preparedness Checklist – HPRA2019-09-17T13:44:34+01:00

Further guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

2019-08-30T12:13:20+01:00

The Medicines & Healthcare products Regulatory Agency (MHRA) have released further guidance on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal. In relation to medicines: The transitional provision in legislation will ensure that all currently granted Centrally Authorised Products (CAPs) automatically become UK MAs on [...]

Further guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal2019-08-30T12:13:20+01:00

Hard-Brexit: MHRA preparations and impact on clinical trials

2019-08-23T10:08:38+01:00

With the appointment of Boris Johnson as Prime Minister, it is likely that the United Kingdom (UK) may leave the European Union (EU) on the 31st of October 2019 and without a deal (“Hard Brexit”). Pharmaceutical authorities see challenges for pharmaceutical manufacturers in many areas, not only in terms of drug availability [...]

Hard-Brexit: MHRA preparations and impact on clinical trials2019-08-23T10:08:38+01:00

Serialisation: A New Guidance for EU Inspectors

2019-07-04T10:46:36+01:00

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

2019-07-01T13:47:50+01:00

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

2019-06-13T13:26:00+01:00

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

2019-05-29T10:39:17+01:00

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

2019-05-22T13:37:36+01:00

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

2019-04-26T10:28:07+01:00

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

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