{"id":1087,"date":"2025-07-24T14:47:06","date_gmt":"2025-07-24T17:47:06","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=1087"},"modified":"2025-07-24T14:47:36","modified_gmt":"2025-07-24T17:47:36","slug":"ich-m4qr2-draft-revision-open-for-public-consultation","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2025\/07\/24\/ich-m4qr2-draft-revision-open-for-public-consultation\/","title":{"rendered":"ICH M4Q(R2): draft revision open for public consultation"},"content":{"rendered":"

As part of the work initiated in 2021 by the International Council Harmonization (ICH), the revision of Guideline M4Q(R1) (in force since 2002) is currently under public consultation. Regarding the quality section of the CTD, module 3 (and section 2.3 of module 2), the document provides information on the characteristics, manufacturing, and control of the medicinal product, popular known as CMC (Chemistry, Manufacturing, and Controls). This is the only complementary guideline within the ICH M4 framework that had not yet been reviewed.<\/p>\n

The new proposal (R2) is available for review and comments and redefines the structure and technical content of the quality module. The objective of this revision is to improve the structure to include registration and post-registration, expand the scope to new and complex products available, and support digital transformation, considering technologies such as continuous manufacturing, artificial intelligence, statistical modeling, platforms, and structured data<\/u> to make regulatory assessment more efficient and accelerate the availability of new drugs to patients.<\/p>\n

The main and most impactful change in Module 3 is that it will become a \u201crepository\u201d for documents that support the information in Module 2. As a result, the quality of Module 2 will be improved, so that it is no longer a simple summary of the information provided in Module 3, but will be standardized to increase efficiency and effectiveness by including benefit-risk discussions, a detailed summary of product development, and general quality information considering the product and the manufacturing process, including a subsection focused on post-registration.<\/p>\n

The new proposal for section 2.3 of module 2 has the following structure:<\/strong><\/p>\n

\u25ab\ufe0f 2.3.1 \u2013 General information (e.g., common name, pharmaceutical form, route of administration);<\/p>\n

\u25ab\ufe0f 2.3.2 \u2013 Overall Development and Overall Control Strategy (QTPP, CQAs, and OCS);<\/p>\n

\u25ab\ufe0f 2.3.3 \u2013 Core Quality Information (CQI): includes essential data for regulatory assessment and life cycle management;<\/p>\n

\u25ab\ufe0f 2.3.4 \u2013 Development Summary and Justification (e.g., formulation studies, impurity control, validation, E&L, adventitious agents);<\/p>\n

\u25ab\ufe0f 2.3.5 \u2013 Product Lifecycle Management (PLCM);<\/p>\n

\u25ab\ufe0f 2.3.6 \u2013 Product Quality Benefit Risk (optional).<\/p>\n

Within section 2.3.3 and module 3, there is also a subdivision following the DMCS model (Description, Manufacture, Control, Storage), for each type of material covered. These materials include drug substance (DS), substance intermediates (SI), starting\/source materials (SM), excipients (EX), impurities (IM), reference material (RS), drug products (DP), product intermediates (PI), medical devices (MD), among others.<\/p>\n

Therefore, this revision is an alignment with other guidelines, such as ICH Q8 to Q14, M7, M9, M13, and allows the connection between concepts of QbD, Design Space, Real-Time Release Testing (RTRT), multivariate models, impurity control, and life cycle. Based on this review, a decrease redundancy is expected, along with changes in structure that will bring flexibility to incorporate all types of drugs and post-registration changes, greater compatibility with the e-CTD digital format, and greater similarity in terms of structure with the safety guideline, M4S (R2), and efficacy guideline, M4E (R2).<\/p>\n

Public participation is available and open to all interested parties. Contributions from Brazil should preferably be written in English using the electronic form (link: electronic form<\/strong><\/a>). The deadline for submitting contributions is September 5, 2025.<\/p>\n

The current stage involves regional collection of contributions. According to the information available on the ICH website, the deadlines are:<\/p>\n

ANVISA, Brazil<\/strong>\u00a0–\u00a0Deadline for comments by 5 September 2025<\/p>\n

EC, Europe<\/strong>\u00a0–\u00a0Deadline for comments by 24 October 2025<\/p>\n

EDA, Egypt<\/strong>\u00a0–\u00a0Deadline for comments by 1 December 2025<\/p>\n

Health Canada, Canada<\/strong>\u00a0–\u00a0Deadline for comments by 25 September 2025<\/p>\n

SFDA, Saudi Arabia<\/strong>\u00a0–\u00a0Deadline for comments by 15 October 2025<\/p>\n

Swissmedic, Switzerland<\/strong>\u00a0–\u00a0Deadline for comments by 24 October 2025<\/p>\n

TFDA, Chinese Taipei<\/strong>\u00a0–\u00a0Deadline for comments by 29 August 2025<\/p>\n

TITCK, T\u00fcrkiye<\/strong>\u00a0–\u00a0Deadline for comments by 24 October 2025<\/p>\n

Further information available at https:\/\/www.ich.org\/page\/public-consultations<\/a><\/p>\n

At Vita Pharma Consulting<\/strong>, we closely monitor international regulatory trends and are ready to support your company in adapting to these new requirements.<\/p>\n

Count on us to assist your company in developing drug products registration and post-registration projects in Latin America and Europe.<\/strong><\/p>\n","protected":false},"author":2,"featured_media":1090,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[26],"yoast_head":"\nICH M4Q(R2): draft revision open for public consultation - Vita<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2025\/07\/24\/ich-m4qr2-draft-revision-open-for-public-consultation\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ICH M4Q(R2): draft revision open for public consultation - Vita\" \/>\n<meta property=\"og:description\" content=\"As part of the work initiated in 2021 by the International Council Harmonization (ICH), the revision of Guideline M4Q(R1) (in force since 2002) is currently under public consultation. 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