The PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) has entered into force on 1 July 2021. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. It marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The feedback received by professional associations across the pharmaceutical industry was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.
_{July 5, 2021}

The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network to oversee the harmonised implementation of the Article 5(3) CHMP opinion on nitrosamines in human medicinal products. The NIOG will be the main interface between regulators and industry to agree on topics requiring further scientific discussion. Click on the bottom to know more about the second meeting of the NIOG. The next meeting is expected to take place in September 2021.
_{June 30, 2021}

If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed. This also applies to manufacturers with their registered place of business in the EU. You may find all the information in the following information sheet.
_{June 23, 2021}

It is an introduction to the basics of electronic submissions in Australia, focusing on the electronic Common Technical Document (eCTD) and non eCTD electronic Submission (NeeS) formats. This information is for users who are new to the TGA’s electronic submissions.
_{June 23, 2021}

To recognize the importance of the monitors/auditors in maintaining a control/verification on the progress of the trial and on the conditions of the subjects, AIFA accepted the proposal made by the AICRO and ASSOMONITOR associations to facilitate the completion of the training of the new monitors/auditors who have already started the training course.
_{June 18, 2021}

EMA has implemented a new system to issue electronically signed and authenticated certificates for human and veterinary medicines on March 30, 2020.
The aim of this ´Questions and Answers´ document is to provide guidance on the format of the electronic certificates issued by EMA, the safety features supporting their authenticity and integrity as well as the Agency´s measures to support the regulatory authorities of importing countries for confirming their validity, in case of any doubt.
_{June 14, 2021}

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”. This guidance document is expected to improve the protection of consumers against contaminants (metals, antioxidants, stabilisers, etc.) potentially released by materials in contact with food (packaging, containers, plates, cups, straws, etc.). It also aims to support the harmonisation of regulatory approaches to consumer health protection across Europe.
_{May 20, 2021}

The new version of the guideline “GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS” has been updated in February 2021 and is now available on the APIC (Active Pharmaceutical Ingredients Committee) website. Updated parts: chapter 4-Acceptance Criteria and 9-Cleaning Validation Protocol.
_{May 14, 2021}

The Italian Medicines Agency (AIFA), in line with what is written in Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) and in the Ministerial Decree April 30, 2015, intends to provide details on the management within the National Pharmacovigilance Network (RNF) of the reports of suspected adverse reactions related to lack of efficacy.
_{May 13, 2021}

EMA recently released draft agenda for “Pharmacovigilance Risk Assessment Committee (PRAC)” meeting conducted in between 03 May 2021 to 06 May 2021 for the assessment of new signals detected from new sources. Assessment for important items are from Item no. 02 to Item no. 09.
_{May 7, 2021}