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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

  • New Solvent Added to ICH Q3C(R6)

    Jan 27, 2017

    ICH Q3C (R6), Impurities: Guideline for Residual Solvents, has entered the implementation period. The most recent update revises the Permissible Daily Exposure for Methyl isobutyl ketone (MIBK) and adds Triethylamine (TEA) as a new solvent.

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  • 16 New Members Officially Join ICH

    Jul 27, 2016

    To advance its mission of becoming a global platform for harmonization for better health, ICH has welcomed two new members and 14 observers who represent regulatory authorities, regional health initiatives and pharmaceutical industry groups at its June meeting. These include:

    • Association of Southeast Asian Nations (ASEAN)
    • Biotechnology Innovation Organisation (BIO)
    • Central Drugs Standard Control Organization (CDSCO, India)
    • Council for International Organizations of Medical Sciences (CIOMS)
    • Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, Mexico)
    • East African Community (EAC)
    • European Directorate for the Quality of Medicines & HealthCare (EDQM)
    • Health Sciences Authority (HSA, Singapore)
    • International Pharmaceutical Excipient Council (IPEC)
    • Ministry of Food and Drug Safety (MFDS, South Korea)
    • Roszdravnadzor (Russia)
    • Food and Drug Administration (TFDA, Chinese Taipei)
    • Therapeutic Goods Administration (TGA, Australia)
    • United States Pharmacopeia (USP)
    • International Generics and Biosimilars Association (IGBA)
    • World Self-Medication Industry (WSMI)
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  • TGA Joins ICH

    Feb 10, 2016

    Australia’s Therapeutic Goods Administration (TGA) has joined ICH as its latest observer, allowing TGA representatives to attend ICH Assembly meetings and participate in ICH activities.

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  • ICH Seeks Reform of Organization

    Nov 12, 2015

    In late October, ICH held its first Assembly and Management Committee meetings. These meetings are part of an overall reform of the organization that seeks to expand ICH into a worldwide initiative that goes beyond current ICH members. In addition, ICH seeks to include a wider selection of representatives from global industry sectors impacted by ICH harmonization.

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  • Solvent Upgraded Due to Health Concerns

    Sep 3, 2015

    The ICH Expert Working Group behind the Q3C Guideline recently revised the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone (MIBK). This was listed in Q3C as a Class 3 solvent. Based on new data suggesting MIBK causes carcinogenic health problems in rodents, the Expert Working Group recommends upgrading MIBK to a Class 2 solvent.

    Comments are due Dec. 31.

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  • ICH M7 Addendum Available for Comment

    Jul 23, 2015

    Following completion of Step 2b of the ICH process, the Addendum for ICH M7 Guideline Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is now available for comment. This addendum complements the current harmonized M7 guideline and summarizes known mutagenic impurities regularly found during synthesis.

    The deadline for comments is January 31, 2016.

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  • Q&A for ICH Q7 Now Available

    Jul 8, 2015

    The Q&A for ICH Q7 has now entered the implementation state. Since the establishment of Q7 in 2000, uncertainties have arisen with regard to interpretation of sections concerning GMP of APIs. The new Q&A document seeks to harmonize regulatory expectations in this area.

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  • ICH Steering Committee Seeking Additional ICH Q11 Information

    Mar 24, 2015

    ICH seeks input concerning its ICH Q11 Q&A document for potential issues that should be included.

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  • ICH Q3D Elemental Impurities Guideline Finalized

    Jan 15, 2015
    In December the ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH process. Now the guidance has entered the implementation period, or Step 5. The ICH Q3D Guideline provides global policy for limiting metal impurities in drug products and ingredients.
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  • ICH Meeting in Lisbon Looks at GMP Quality Updates

    Dec 17, 2014

    In Q4, the ICH Steering Committee along with its Expert Working Groups met in Lisbon. Among the topics under discussion were GMP-related Quality Updates. These included agreeing upon the final set of Q7 Q&As on APIs, convening the new Expert Working Group on Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management (Q12), and approving a concept paper and business plan for developing Q11 Q&As to clarify selection of starting materials and information that needs to be provided for marketing authorization applications.

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  • Final Concept Paper on ICH Q12 Endorsed

    Nov 24, 2014

    The ICH Steering Committee recently endorsed the final concept paper Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This new document offers guidance on building a framework to facilitate efficient management of postapproval CMC changes.

    ICH Q12 is a continuation of the Q8–Q11 guidelines and seeks to promote innovation, continual improvement while also strengthening QA and reliable supplies of the product.

    ICH plans adoption of a Step 2 document in 2016.

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  • ICH Guideline on DNA Reactive Substances Recommended for Adoption

    Jul 24, 2014
    The final draft of the ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is being recommended for adoption by EU, Japanese and U.S. regulatory authorities.
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