HomeCategoryArchiwa Pharmaceutical industry - Regulatory Compliance

EU: Update of the EU drug precursor list    The EU Comisson has published an update of the EU drug precursor list.  The initiative aligns with the European Commission’s 2025 Work Programme under the “Security” priority and builds on the Drugs Package adopted on 4 December 2025 to address illicit drug production. This package includes both the...

South Korea: Amendments to the Regulation for Pharmaceutical Approvals   South Korea has announced planned amendments to the Regulation for Pharmaceutical Approvals, Notifications and Reviews.  The changes will be implemented by MFDS Notification No. 2026-274. The following changes are planned by the Ministry of Food and Drug Safety of the Republic of Korea: If only...

EU: Drug precursors – EU legislation (revised rules)   The EU has announced a new legislative initiative to revise its rules on drug precursors. The proposal seeks to revise the legislation governing the monitoring of trade in drug precursors both within the Union and between the Union and third countries. It addresses a number of...

EU: New ‘Pharma package’   The Council and the European Parliament have reached a deal on the new “pharma package,” a legislative overhaul designed to improve patient access to medicines and strengthen the competitiveness and fairness of the EU pharmaceutical sector. This comprehensive reform modernises EU pharmaceutical rules to ensure that safe, effective and affordable...

Philippines: New regulations of pharmaceuticals   Philippines have published two new pharmaceutical regulations: Implementing Guidelines of the World Health Organization (WHO) Collaborative Procedure on the Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRAs); Classification of Pharmaceutical Products Intended for Human Use Regarding the first issue, many countries—including the Philippines—continue to face difficulties in...

EU: Amendment on chemical substances classified as drug precursors   The EU has published a draft Commission Delegated Regulation amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain precursors of synthetic cathinone and amphetamine in the list of scheduled...

EU: Critical Medicines Act – new staff working document   The EU Commission has published a new staff working document regarding the draft Critical Medicines Act. The working document summarizes evidence supporting the legislative proposal laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability...

EU : Draft Critical Medicines Act published for comments   The EU Commission has published a proposal for the new Critical Medicines Act.  The ful name of the regulation is Regulation laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal...

China: Regulations on the Supervision and Administration of Drug Production for Export   China has published new Regulations on the Supervision and Administration of Drug Production for Export. The purpose of the “Regulations on the Supervision and Administration of Drug Production for Export” is to regulate the drug manufacturing activities of Chinese manufacturers exporting drugs...

EU: Proposal for a Critical Medicines Act The EU Commission is consulting a Proposal for a Critical Medicines Act. The European Union is grappling with a growing shortage of medicines, posing a serious risk to public health and patient care across its Member States. This issue is particularly concerning for critical medicines, where alternative treatments...