General News

Safety is top concern for recent U.S. drug importation proposal

2019-08-19T11:20:19+01:00

Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan”. The action plan would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a [...]

Safety is top concern for recent U.S. drug importation proposal2019-08-19T11:20:19+01:00

What is considered GMP-compliant equipment design?

2019-08-15T10:11:08+01:00

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 [...]

What is considered GMP-compliant equipment design?2019-08-15T10:11:08+01:00

Canada’s Cannabis Products: New Regulatory Approach

2019-07-11T11:10:55+01:00

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 [...]

Canada’s Cannabis Products: New Regulatory Approach2019-07-11T11:10:55+01:00

Medicinal cannabis now being made available under a pilot programme

2019-06-28T13:55:16+01:00

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 [...]

Medicinal cannabis now being made available under a pilot programme2019-06-28T13:55:16+01:00

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands

2019-06-13T13:24:29+01:00

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, [...]

The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands2019-06-13T13:24:29+01:00

Aer Lingus Cara Magazine Interview

2019-04-05T13:18:37+01:00

Now featuring in this month's in-flight Aer Lingus Cara magazine, an interview with our CEO, Ann McGee. The interview titled 'A day in the life' comes following our win at the 'Aer Lingus Start Up Awards 2018'. The interview provides a great insight into the daily routine of Ann and her busy [...]

Aer Lingus Cara Magazine Interview2019-04-05T13:18:37+01:00

EMA now operating from Amsterdam

2019-03-13T14:39:05+01:00

Following the European Medicines Agency leaving its London premises on 1 March, the agency is now operating from Amsterdam. The staff will gradually move into the Spark building in Amsterdam Sloterdijk. The EMA has been working hard with the Dutch authorities to ensure these temporary premises would be ready to move into [...]

EMA now operating from Amsterdam2019-03-13T14:39:05+01:00

Are there Brexit contingency plans for the pharmaceutical industry?

2019-04-26T10:31:57+01:00

In relation to the decision on whether a deal will be made or not on Brexit, the outcome will have a big threat on pharmaceutical research and manufacturing in the United Kingdom, the industry has said. This will potentially be driving up manufacturing costs and minimising future investment. A range of companies [...]

Are there Brexit contingency plans for the pharmaceutical industry?2019-04-26T10:31:57+01:00

EU-FDA MRA: Soon all States on board

2019-02-20T10:25:10+01:00

The EU Mutual Recognition Agreement (MRA) with the USA was increased by two further countries. The companies that have been included are Poland and Slovenia. At present, there is a total of 22 countries recognised. Germany is still missing from this Mutual Recognition. A deadline has been established for all authorities and [...]

EU-FDA MRA: Soon all States on board2019-02-20T10:25:10+01:00

UK amends GMP and GDP Regulations

2019-02-01T14:10:03+01:00

There is still a very strong possibility that there will be a “Hard Brexit”. The term “Hard Brexit” refers to the United Kingdom leaving the European Union without a deal. The UK Government is now preparing legislation to allow the continued sale of and access to medicines manufactured in the remaining EU. [...]

UK amends GMP and GDP Regulations2019-02-01T14:10:03+01:00

Recent Posts

Contact Info

MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Ireland

Phone: +353 (01) 846 3605