Pharmaceutical firms should let the EMA know about minor variations to marketing authorisation (MA) by the end of next month if they want to avoid delays over the festive period.
in-Pharmatechnologist.com presents a round-up of the latest regulatory developments, including a guide for GMP newbies from Health Canada, an internationally-flavoured revision of the EMA’s rules on batch certification and the EDQM’s latest thoughts membrane-based...
Baxter has shut down a production area at its plant in Castlebar, Ireland, telling the EMA it cannot guarantee peritoneal dialysis (PD) solutions made there are free of endotoxin contamination.
The European Medicines Agency (EMA) has highlighted the quality APIs manufactured outside the EU as an area of concern in the draft 2015 road map it unveiled this week.
The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country.
Cost pressure and the increasing complexity of trials is forcing drugmakers to increasingly turn to outsourcing experts for clinical development, according to a Kalorama Information report.
Venus Remedies’ oncology facility has received EMEA GMP accreditation, making it one of very few Indian contract manufacturers licensed to make cancer treatments for the European market.
There are some areas of the European approval system
for biosimilars that still need to be clarified, a panel of
industry experts said during BIO 2007.
According to a new report, the demand for worldwide drug packaging
is expected to reach new heights, predicting growth of 5.3 per cent
annually to $24.3 billion (€20 7 billion) in 2009, driven by aging
demographic patterns increasing...
Regulatory action on the COX-2 inhibitors was still a possibility
as the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) held hearings with Pfizer, Merck Sharp &
Dohme and Novartis regarding...
The structure and remit of the European Medicines Evaluation Agency
(EMEA) will be overhauled from 20 May to give it a stronger
advisory role to industry, the healthcare profession and patients.