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News from the world

12

Oct

New USP chapter details lifecycle approach to analytical testing

The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the goal of easing the process for instituting post-approval changes for analytical methods. The chapter will become official on 1 May 2022.
 
The USP chapter complements efforts underway at International Council for Harmonisation to develop a Q14 guideline to make it easier for manufacturers to switch analytical methods for testing medicines...[RAPS-USP]

11

Oct

Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6

At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted...

06

Oct

China’s NMPA applies for pre-accession to PIC/S

On 24 September 2021, China’s National Medical Products Administration (NMPA) submitted an application...

06

Oct

US FDA - Drug Registration Renewal Period Now Open

The annual drug registration renewal period is now open through December 31, 2021. To keep...

04

Oct

AIFA - Estensione automatica della scadenza dei certificati GMP durante l’emergenza COVID-19 al 31.12.2022

...tutti i certificati GMP già scaduti o in scadenza, sia di produzione che di importazione...

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