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Medicines Under Additional Monitoring

In the dynamic world of pharmaceuticals, it's imperative for pharmaceutical companies to remain informed about new developments that prioritize patient safety and promote responsible medication use. Today, we're shedding light on "The List of Medicines Under Additional Monitoring," which was last updated in October 2023.

What's Behind "The List of Medicines Under Additional Monitoring"?

Well, it's all about keeping a closer eye on certain medicines. If you spot a black inverted triangle (▼) on their package leaflet or Summary of Product Characteristics (SmPC)...

Let's Talk Big Data in Pharma: Transforming Healthcare together !

Let’s dive into something that's reshaping the landscape of the pharmaceutical industry: Big Data.

Big Data isn't just a trend; it's a revolution. Imagine vast amounts of data from clinical trials, patient records, genomics, spontaneous adverse drug reaction reports and even social media insights. But it's not about the size; it's about what we can DO with it!

International women's day

Every year on 8th March, International Women's Day is celebrated in many countries. This day, is dedicated to celebrating victories and achievements in women's rights and to reaffirming the importance of the struggle for women's rights and gender equality.

International Women's Day, established in 1977 by the United Nations (UN). ....

Revision of the EU pharmaceutical legislation - the largest reform in over 20 years

On 26 April 2023, the European Commission presented its project to revise the EU's pharmaceutical legislation. This revision, which is part of the Pharmaceutical Strategy for Europe presented by the European Commission in November 2020, is the first major update of pharmaceutical legislation since 2004.

This reform aims to create a sustainable...

Applying for orphan drug designation (ODD)

An orphan medicinal product is a medicine for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Union) or where the medicine is unlikely to generate sufficient profit to justify research and development costs. 

About 30 million people living in the European Union (EU) suffer from a rare disease.

Orphan designation can only be granted in the EU, by the European Commission, 

CTIS use is now mandatory for new clinical trials in the EU/EEA

The new Clinical Trials Regulation (Regulation (EU) No 536/2014) entered into application on 31 January 2022, repealing the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States.

The Clinical Trials Regulation (CTR) harmonizes and streamlines the submission, assessment and supervision processes for clinical trials in the EU through the Clinical Trials Information System (CTIS)...

Sanctions to pharmaceutical companies for shortage of medicines

The French National Agency for the Safety of Medicines and Health Products (ANSM) has updated on 08/08/2022 its guidelines for the determination of financial penalties in case of non-compliance of pharmaceutical companies with the regulation of medicinal products for which they are responsible:

• New non-compliance cases subject to financial penalties are now listed in an Annex 3....

(Read more)

Today is the rarest day of the year

Since its creation in 2008, Rare Disease Day has played a key role in building an international rare disease community working towards equality in terms of social opportunities, healthcare and access to diagnosis and therapies for people living with rare diseases.

Rare Disease Day, the rarest day of the year, is organised every year on 28 February (or 29 in leap years). 

What is a rare disease? (Read more)

Role and duties of the Qualified Person (QP) in France

The Qualified Person is a privileged function in France. Placed at the heart of the board of directors of the French pharmaceutical companies, the QP accumulates several responsabilités and is the privileged interlocutor of the Health authorities. The Qualified Person is the guarantor of the respect of the French Health Code (CSP) inside the pharmaceutical company, and more generally, of medicines' safety (...)

Pharmacovigilance local literature review: day zero

Marketing Authorisation Holders (MAHs) are required to monitor scientific and medical literature and to report individual cases of suspected adverse reactions for medicinal products, for which they hold a Marketing Authorisation in the EEA.

The literature review includes literature on the benefit/risk profile of the product and not just individual cases of suspected adverse reactions (also referred to as individual case safety reports (ICSRs)). It should also identify any emerging safety issues (ESI)...

Guidelines on Good Manufacturing Practice for Investigational medicines

In clinical trials there may be added risk to the subjects compared to patients treated with authorised medicinal products.

Investigational medicinal products are therefore manufactured by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject and the reliability and robustness of clinical data generated in the clinical trial (article 63, paragraph 1, Regulation (EU) n° 536/2014)....

Medicine prices: is France still an attractive market?

In the European Union, decisions on pricing and reimbursement of medicinal products are made at a national level following negotiations between governments and Marketing Authorisation Holders (MAH). 

In France, after obtaining a Marketing Authorisation (MA) for a medicinal product, a pharmaceutical company can freely establish its price. However, in order for it to be reimbursed by French social security, the company must submit...

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The Qualified Person (QP) a key function in the French pharmaceutical companies