盘点→最新国际医药政策合集[Apr-2 2022]

文摘健康医疗 2022-04-26 10:30 上海

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本篇摘要

以下整理分享最新发布的7项国际医药政策法规时事，包括：

MHRA发布更新版《药物临床试验的管理授权及报告安全问题》指南、更新版《出口英国生产的活性物质的书面确认流程》指南；EC发布更新版《生物类似药临床试验药物的质量文件要求》指南草案、更新版《临床试验药物的化学与药学质量文件要求》指南、更新版《临床试验中使用IVRS/IWRS》反思文件；瑞士药监Swissmedic发布更新版《提交人类医药产品HMP的ICH E2E风险管理计划RMP》指南；FDA发布《抗体-药物偶联物的临床药理学考虑》指南草案。

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Whenever you find yourself on the side of the majority, it is time to pause and reflect.

每当发现自己和大多数人站在同一边时，就该停下来反思一下。

– Mark Twain

MHRA发布更新版《药物临床试验的管理授权及报告安全问题》指南

Clinical Trials for Medicines: Manage your Authorisation, Report Safety Issues

On 7 February 2022 the MHRA updated the guidance on managing the clinical trial authorization, reporting safety issues and completing the end-of-trial study report.

As of 1 January 2022 the combined review service, formerly known as Combined Ways of Working (CWoW), is now the way that all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are prepared, submitted and reviewed. Combined review offers a single application route and co-ordinated review leading to a single UK decision for CTIMPs.

Please note: CTIMP initial applications via combined review should be started and submitted using the new part of Integrated Research Application System (IRAS) and not in the standard part of IRAS. While the regulatory requirements and fees remain the same, the application submission, processing and assessment steps outlined below refer to non-combined review applications. For Combined review applications please refer to the Health Research Authority website.

https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues

MHRA发布更新版《出口英国生产的活性物质的书面确认流程》指南

Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland

On 7 February 2022 the MHRA updated the guidance on how to operate the ‘Written Confirmation’ process for active substances manufactured in Great Britain.

A Written Confirmation confirms that, for a third country exporting Active Substances to the EEA:

• the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA

• the manufacturing plant is subject to regular inspections (which may be both announced and unannounced)

• significant non-compliance events would be communicated to the EEA without delay

A template for the Written Confirmation can be found on the European Commission website. The requirement for the Written Confirmation is stated in Article 46b(2)(b) of Directive 2001/83/EC.

https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain

EC发布更新版《生物类似药临床试验药物的质量文件要求》指南草案

Update - Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

On 4 February 2022 the European Commission announced the updated draft guideline on the requirements to the biological IMPs quality documentation in clinical trials, revision 2.

This guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMPs containing biological / biotechnology derived substances.

Moreover, this guideline lists, as regards documentation on the biological, chemical and pharmaceutical quality of the IMP, examples of modifications which are typically considered as 'substantial'.

The guidance outlined in this document applies to proteins and polypeptides, their derivatives, and products of which they are components (e.g. conjugates). These proteins and polypeptides are produced from recombinant or non-recombinant cell-culture expression systems and can be highly purified and characterised using an appropriate set of analytical procedures. The guideline also applies to Auxiliary Medicinal Products containing these proteins and polypeptides as active substances. The requirements depend on the type of the product (authorised / not authorised / modified / non-modified medicinal product).

https://ec.europa.eu/health/latest-updates/update-guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal-2022-02-04_en

EC发布更新版《临床试验药物的化学与药学质量文件要求》指南

Update - Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials

On 4 February 2022 the European Commission announced the updated guideline on the requirements to the chemical and pharmaceutical IMPs quality documentation in clinical trials, revision 2.

This guideline addresses the documentation on the chemical and pharmaceutical quality of IMPs and Auxiliary Medicinal Products containing chemically defined drug substances, synthetic peptides, synthetic oligonucleotides, herbal substances, herbal preparations and chemically defined radioactive/radio-labelled substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans. It includes the requirements for IMPs and Auxiliary Medicinal Products to be tested in phase I, phase II, phase III and phase IV studies as well as the requirements for modified and unmodified comparator products and IMPs to be tested in generic bioequivalence studies.

When compiling the quality part of the IMPD for phase II and phase III clinical studies, the larger and longer exposure of patients to the product have to be taken into account compared to phase I clinical studies. Based on the diversity of products to be used in the different phases of clinical trials, the requirements defined in this guideline can only be of an illustrative nature and cannot be expected to present an exhaustive list. IMPs based on innovative and/or complex technologies may need more detailed data to be submitted. For certain situations, e.g. where the drug substance from the specific source to be used for an IMP is already included in a medicinal product authorised within the EU, not all the documentation outlined in the following chapters need to be submitted in the IMPD, but a simplified IMPD will suffice.

https://ec.europa.eu/health/latest-updates/update-guideline-requirements-chemical-and-pharmaceutical-quality-documentation-concerning-2022-02-04_en

EC发布更新版《临床试验中使用IVRS/IWRS》反思文件

Updated Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials, with Particular Emphasis on the Handling of Expiry Dates

On 4 February 2022 the EMA announced the new version of the reflection paper on the use of IRTs in clinical trials.

This reflection paper was initially published on 10 December 2013 under reference EMA/INS/GCP/600788/2011. It was updated in view of the entry into application of the Clinical Trials Regulation (CTR) No. 536/2014, only to clarify that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the CTR (see section 2.3 of the reflection paper). The rest of the reflection paper was not reviewed and reflects the state of thinking at the time of initial publication. Additional information on the expected requirements for interactive response technologies may be found in the Guideline on computerised systems and electronic data in clinical trials, once finalised.

This paper seeks to provide guidance on what national competent authorities (NCAs) expect from such systems and in particular their use for handling of the expiry date of the Investigational Medicinal Product (IMP). These positions will form suggestions for sponsors and IRT providers on the validation requirements for systems. Specific computer system validation is not discussed in detail since this is the subject to a large number of other publications. This paper is aimed at sponsors and providers of such systems.

Currently, the information surrounding the use of IRT in the clinical trial authorisation (CTA) applications is only included with reference to IRT use in randomisation where this function is outsourced. As a consequence, the NCA might have little knowledge of the extent of use of these systems, particularly where the system is an in-house one. For this reason, it would be helpful if Appendix I be completed by the sponsor and submitted to the NCA along with the CTA.

https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-interactive-response-technologies-interactive-voice/web-response-systems-clinical-trials-particular-emphasis-handling-expiry-dates_en-0.pdf

瑞士药监Swissmedic发布更新版《提交人类医药产品HMP的ICH E2E风险管理计划RMP》指南

Update to the Guidance Document “Risk Management Plan (RMP) ICH E2E Information for Submission Human Medicinal Product (HMP)”

On 15 February 2022 the Swissmedic announced the updated guidance on RMP ICH E2E information for submission HMP.

Based on established common practice, clarifications on the obligation to submit an RMP in connection with applications for authorisation have been added to section 6.

Experience has shown that RMP updates were also being submitted to Swissmedic for review when no relevant content changes had been made. In light of this, the RMP update submission requirements in section 7.1 and its subsections have been clarified and/or redefined.

The “Switzerland-specific Annex (SSA)” on RMP has been newly included. This substantiates and presents any deviations as regards safety concerns or implementation of pharmacovigilance activities or risk-minimising measures in Switzerland relating to the RMP submitted (usually EU RMP).

Submission of study results from the pharmacovigilance plan, of educational materials and of RMP summaries have been addressed in sections 9 and 10.

The revised guidance document is valid with effect from 1st of march 2022.

https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/risk-management--psurs--pv-planning-.html

FDA发布《抗体-药物偶联物的临床药理学考虑》指南草案

Clinical Pharmacology Considerations for Antibody-Drug Conjugates

On 7 February 2022 the FDA published the draft guidance. Comments may be submitted by 6 May 2022.

This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small molecule drug or payload. Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs).

https://www.fda.gov/media/155997/download

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