China and U.S. Sign Agreement About Product Safety

On Dec. 11, 2007 the U.S. Department of Health and Human Services (HHS) and the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China signed two Memorandums of Agreement, one to enhance the safety of drugs and medical devices and another for the safety of food and feed.

To enhance the safety of products sold in the United States, Chinese authorities will implement two programs, both subject to an audit by the U.S. FDA. The first will require exporters to the United States to register with AQSIQ and agree to annual inspections to ensure their goods meet U.S. standards. AQSIQ will notify HHS/FDA of those that fail inspection and why. HHS/FDA will maintain an online list of registered companies. AQSIQ will also notify HHS/FDA of all companies AQSIQ suspended or that have lost their registered status. AQSIQ will implement a system to trace products from the source of production or manufacture to the point of exportation.

Second, new certification requirements will help ensure products exported from China to the United States meet U.S. standards. Once AQSIQ’s Inspection Bureau confirms a shipment meets HHS/FDA requirements, it will issue a certificate that carries a unique identifying number, which AQSIQ will file with HHS/FDA.

Each party also commits to notify the other within 48 hours of the emergence of significant risks to public health related to product safety, recalls and other situations.

HHS/FDA can request a timely investigation regarding any covered product if there is reason to believe it could pose a health or safety risk.

ICH GL10 Revised

Revised veterinary ICH GL10, Impurities in New Veterinary Drug Substances, was released on November 26. 
The revised guidance provides support regarding the development of registered applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region or member state.

ICH GL11 Revised

Revised Veterinary ICH GL11, Impurities in New Veterinary Medicinal Products, was released on November 26.   The guidance addresses only impurities found in new veterinary medicinal drug products classified as degradation products.
The revised guidance also provides advice regarding the development of registration applications for the approval of veterinary medicinal products in the three ICH regions.

ICH GL3 Revised

The Revised Veterinary ICH GL3, Stability Testing of New Veterinary Drug Substances and Medicinal Products was released on November 26.
The revised guidance provides assistance regarding the development of stability testing data for new animal drug applications in the three ICH regions.

ICH Q10 Adopted for Consultation

The International Conference on Harmonization Steering Committee and its expert working groups met in Brussels on May 6-10, 2007. This meeting highlighted the progress made in the area of pharmaceutical quality and manufacturing. The Steering Committee adopted for consultation a new guideline, “Pharmaceutical Quality Systems” (Q10) which will complement existing Good Manufacturing Practices (GMPs) with modern quality systems elements. The document is not yet available for comment.
This guideline complements the recently adopted guidelines on “Pharmaceutical Development” (Q8), which describes what should be submitted to a regulatory authority and “Quality Risk Management” (Q9), which provides principles and examples of quality risk management that can be applied to all aspects of development and manufacture of a medicinal product, including aspects of inspection. Together these guidelines form the foundation for a modern risk-based approach to pharmaceutical quality and manufacturing.

Please visit the ICH website for more information.

ICH Q10 Published for Comment

The ICH Q10 Guideline on Pharmaceutical Quality Systems (ICH Q10) was released for Step 2 consultation at the ICH Steering Committee meeting earlier this month. This will now be published in the three ICH Regions for public comment. PDA has a Task Force under the RAQC to develop our comments on this document. The Task Force is led by Louise Johnson, Vertex Pharmaceuticals. 

Click here to view the Q10 Guideline or visit the ICH website for more information.

Argentinean and South African Health Authorities to Join PIC/S

At the May 15-16 joint committee meeting of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the committee invited South Africa’s Medicines Control Council and Argentina’s National Institute of Medicaments to join as new Participating Authorities. Applications for the health authorities in Israel, Lithuania, Thailand and the United States were reviewed.

Among the other business completed at the meeting was the extension of Jacques Morénas term of service as PIC/S chairman until the end of 2008.

To learn more, please visit the PIC/S website.

PDA Regulatory Affairs and Quality Control Committee (RAQC) Sponsors Formation of Task Force Regarding Forthcoming ICH Q10 Guidance

The PDA Regulatory Affairs and Quality Control Committee (RAQC) is sponsoring the formation of a task force to review, evaluate and facilitate discussion and comments regarding the forthcoming ICH Q10 Guidance, "Pharmaceutical Quality Systems". This task force will be chaired by Louise Johnson who is a board member of RAQC. Interested persons should contact Bob Dana, Vice President Quality and Regulatory Affairs at dana@pda.org.

Quality Risk Management ICH Q9 Briefing Pack

Introduction

ICH Q9 together with ICH Q8 and Q10 is one of the ICH Q-topics that encourage further development science based and risk based approaches to quality. The intention of ICH Q9 is to focus the behaviours of industry and regulatory authorities on the two primary principles of Quality Risk Management, which are:

The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and

The level of effort, formality and documentation of the Quality Risk Management process should be commensurate with the level of risk.

To support the implementation of Quality Risk Management into daily operations for Regulators and Industry some members of the ICH Q9 Expert Working Group have prepared a set of slides, which are intended to be used for information purposes in industry, regulators and other facilitators. For further information, see details at the ICH Homepage.