NOTICIAS Y EVENTOS

The first version of the Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing and the associated templates were finalised in March and April 2023 and are now available on the APIC website.

The European Medicines Agency (EMA) publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through to EMA’s evaluation of authorisation applications, post-authorisation changes, safety reviews and withdrawals of authorisation.

On 17th of May 2023, EMA published recommendations for industry on the good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.

According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG).

The European Medicines Agency (EMA) has published a new version of the "3-year work plan for the Quality domain" for the period January 2021 - December 2023.

In order to protect public health, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: the JAZMP)  shall, with regard to medicinal products without marketing authorisations in the Republic of Slovenia in accordance with paragraphs one and two of Article 20 of the Medicinal Products Act (Off. Gazette of the RS, No. 17/14 and No. 66/19, hereinafter: the ZZdr-2), begin implementing the provisions of Article 54 of the ZZdr-2, which transposed Article 126a of Directive 2001/83/EC into Slovenian law.

On 26th of April 2023, the European Commission published proposal for the reform of the EU's pharmaceutical legislation and a proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with Annex.

Danish, German, Dutch, Norwegian and Swedish authorities prepared the restriction proposal of around 10 000 per- and polyfluoroalkyl substances (PFASs).

The pharmaceutical industry is calling for a modernization of the current variations system to reflect advancements in technology and regulatory needs.

In March this year World Health Organization (WHO) published a draft guideline on GMP for excipients used in pharmaceutical products.

ISO 13485 is the internationally recognized quality management standard for medical devices. It outlines a set of quality management requirements that must be met by medical device suppliers and service providers. This article provides an overview of the standard, including its requirements, who should use it, and how to use it.

The ICH published a 29-page presentation on the revision of ICH Q9 on 14th of March 2023.

The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance and recommendations on mitigating and preventing the presence of nitrosamines in human medicinal products.

To ensure effective planning and execution of a clinical performance study, it is recommended to generate a clinical performance study protocol (CPSP), also referred to as a clinical performance study plan in the In Vitro Diagnostic Regulation 2017/746.