ISPE is launching a new program, Enabling Global Pharma Innovation: Delivering for Patients in support of many regulatory agencies’ ambitions to promote introduction of innovative pharmaceutical manufacturing. It is incumbent for industry to modernize and innovate pharmaceutical manufacturing to improve efficiency and increase confidence in quality assurance for the benefit of...
What is Commenting?
As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we are able to provide that input.
ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC)...
ISPE’s long-time Asia-Pacific Regulatory Advisor Bob Tribe retired from ISPE at the end of 2022, bringing to a close more than 18 years of service to the Society.
On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines.
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)1
Do you have your finger on the pulse of regulatory concerns in the Asia-Pacific Region? Would you like to discuss strategies to meet regional challenges? Are you interested in regulatory harmonization? If so, we’d like to re-introduce ISPE’s Regulatory Quality Harmonization Committee (RQHC)’s Asia-Pacific Regional Focus Group (A-P RFG).
At the 2022 ISPE Europe Annual Meeting held in Madrid on 25-27 April 2022, Evdokia Korakianiti, Head of Quality and Safety, European Medicines Agency (EMA), gave a keynote presentation of EMA’s approach to...
ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived...
