Regulatory & Pharma News Update August 2015

Transcription

1 Regulatry & Pharma News Update August 2015 REGULATORY NEWS Draft Addendum t ICH E6 Released ICH E6(R1) (Guideline fr Gd Clinical Practice) has been in place since 1996 but is underging revisin in the frm f an addendum (ICH E6(R2)) t encurage implementatin f imprved and mre efficient appraches t clinical trial design, cnduct, versight, recrding and reprting while cntinuing t ensure human subject prtectin and data integrity. This addendum has nw been released fr cmment and is available n the ICH website. The revised guideline includes mre detail n areas that have been ht tpics frm GCP inspectins in recent years. The changes include the fllwing: Sectin 1, Glssary - the fllwing definitins have been added t the glssary: Certified cpy Mnitring Plan Validatin f Cmputerised Systems Sectin 2, The Principles f ICH GCP an additinal sentence has been added t 2.10 s that it nw reads All clinical trial infrmatin shuld be recrded, handled, and stred in a way that allws its accurate reprting, interpretatin and verificatin. This principle applies t all recrds (paper r electrnic) referenced in this guideline. Sectin 4, Investigatr the fllwing additins have been made: The investigatr is respnsible fr supervising any individual r party t whm the investigatr delegates study tasks cnducted at the trial site If the investigatr/institutin retains the services f any party t perfrm study tasks they shuld ensure this party is qualified t perfrm thse study tasks and shuld implement prcedures t ensure the integrity f the study tasks perfrmed and any data generated The investigatr shuld maintain adequate and accurate surce dcuments and trial recrds that include all pertinent bservatins n each f the site s trial subjects. Surce data shuld be attributable, legible, cntempraneus, riginal, accurate and cmplete. Changes t surce data shuld be traceable, shuld nt bscure the riginal entry and shuld be explained if necessary (e.g., via and audit trail). Sectin 5, Spnsr the fllwing additins/amendments have been made: TMQA 18E Libertn Brae, Edinburgh EH16 6AE, Sctland, UK t: +44 (0) f: +44 (0) e: inf@tmqa.c.uk

2 5.0 Quality Management this is a new sub sectin which includes: Critical Prcess and Data Identificatin, Risk Identificatin, Risk Evaluatin, Risk Cntrl, Risk Cmmunicatin, Risk Review, Risk Reprting an additinal sentence has been added which reads The spnsr shuld ensure versight f any trial-related duties and functins carried ut n its behalf an additinal sentence has been added which reads The spnsr shuld dcument apprval f any subcntracting f trial-related duties and functins by a CRO (b) additinal wrding added which indicates what SOPs shuld cver (h) new pint which reads Ensure the integrity f the data including any data that describe the cntext, cntent and structure f the data. This is particularly imprtant when making changes t the cmputerised systems, such as sftware upgrades r migratin f data additinal wrding has been added t prvide mre guidance in relatin t the extent and nature f mnitring. It defines n-site mnitring and centralized mnitring (e) new pint which reads Mnitring results shuld be prvided t the spnsr (including apprpriate management and staff respnsible fr trial and site versight) in a timely manner fr review and fllw-up as indicated. Results f mnitring activities shuld be dcumented in sufficient detail t allw verificatin f cmpliance with the mnitring plan Mnitring Plan this additinal sub-sectin prvides guidance n what shuld be detailed in the mnitring plan additinal wrding added t describe what actin shuld be taken in the event f significant nn-cmpliance with the prtcl, SOPs, GCP and/r applicable regulatry requirements and als makes mentin f serius breaches f the trial prtcl r GCP. Sectin 8.1 Essential Dcuments fr the Cnduct f a Clinical Trial, Intrductin further guidance n essential dcument expectatins has been added. The deadline fr cmments n this draft addendum t ICH E6(R1) is 31 January A ddendum_step2.pdf MHRA GPvP Inspectins f Cntract Service Prviders The Medicines and Healthcare prducts Regulatry Authrity (MHRA) has embarked n a recent initiative t evaluate the feasibility f cnducting stand-alne inspectins f pharmacvigilance cntract service prviders. In July 2003 the MHRA intrduced a statutry pharmacvigilance inspectin prgramme f marketing authrisatin hlders (MAHs) in the UK. The revised 2010 EU pharmacvigilance legislatin and Gd Vigilance Practice (GVP) guidance has further strengthened the remit f the MHRA t inspect rganisatins that prvide cntract services fr pharmacvigilance. It s increasingly cmmn fr MAHs t utsurce pharmacvigilance activities t a cntract service prvider. Since the MHRA currently inspect the pharmacvigilance systems, prcesses and prcedures during their inspectins f a MAH, this means that the activities undertaken by a particular pharmacvigilance cntract service prviders may underg review by the MHRA multiple times, Page 2 f 5

3 depending n the number f MAHs wh have subcntracted activities t that cmpany. The cst f inspecting a cntract service prvider is cvered by the fee charged t a particular MAH and the repeated inspectin f a cntract service prvider invlves repeated csts. By implementing fee-bearing pharmacvigilance inspectins f service prviders this culd benefit bth the service prviders and the MHRA by: Pssibly reducing the number f times a service prvider wuld be inspected Reducing the frequency fr each MAH t individually audit their service prviders, as part f the MAH s risk-based audit prgramme Pssibly allcate MHRA resurce where required in a risk-based fashin it may be pssible t cver the activities that supprt multiple MAHs at a single inspectin f that service prvider, which may result in a reduced inspectin scpe f MAH inspectins, where a service prvider had previusly been evaluated as part f a stand-alne inspectin (althugh an evaluatin f interfaces and versight by the MAH may still be required). In Octber 2014 the MHRA cntacted 22 cntract service prviders and ffered them the pprtunity t cmplete a survey aimed at helping the MHRA assess the feasibility f cnducting stand-alne inspectins f pharmacvigilance cntract service prviders. As part f the survey vlunteers were requested t participate in a pilt phase f fee-bearing inspectins, planned fr the financial year f 2015/2016. Of the 22 cntract service prviders cntacted, 10 respnded t the survey and f these 7 vlunteered t participate in the pilt phase. Currently 2 rganisatins have been cntacted fr inspectin by the MHRA s GPvP inspectrate. These inspectins are due t take place in Q2 and Q3 2015/ MHRA Enfrces EC Decisin in Relatin t GVK Bisciences In line with the Eurpean Cmmissin s (EC) decisin (16 Jul 2015), the MHRA has suspended a number f prducts fr which authrisatin was based n clinical studies cnducted at GVK Biscience s site in Hyderabad, India. Only generic medicines are affected, therefre alternatives t suspended prducts are readily available. The prducts which have been suspended are deemed nncritical t cntinuity f supply t the UK market. Prducts necessary fr cntinuity f supply and thse nn-critical prducts fr which further data in supprt f the marketing authrisatin has been prvided, have nt been suspended. The EC endrsed the recmmendatin f the Eurpean Medicines Agency s (EMA) Cmmittee fr Medicinal Prducts fr Human Use (CHMP) t suspend a number f licenses fr generic medicines, fr which authrisatin was based n clinical studies cnducted at GVK Bisciences site in Hyderabad, India. The actin t suspend a number f prducts is a precautinary measure and there is n evidence f safety cncerns r lss f efficacy f these prducts. Page 3 f 5

4 EMA Launches Pilt in Relatin t Pst-Authrisatin Safety Studies The EMA is launching a 12-mnth pilt t encurage cmpanies t seek scientific advice fr pstauthrisatin safety studies (PASS) fr medicines. This vluntary, ptinal prcedure will help t imprve the design f studies meant t cllect further infrmatin n a medicine s safety nce it is n the market. The main fcus f the pilt will be n PASS studies which are nt a cnditin t the marketing authrisatin. By requesting scientific advice, this shuld assist develpers in putting tgether high-quality safety studies that can prvide useful infrmatin n a medicine in a real-life setting, in the interest f patients. The EMA is publishing updated questins and answers t give mre details n this prcedure, as well as a letter f intent cmpanies shuld send t the EMA t submit a request fr scientific advice. ail_ jsp&mid=wc0b01ac058004d5c1 EMA Revises Guidelines n Implementatin f Fast Track Rutes fr Medicines that Address Unmet Medical Needs The EMA has revised its guidelines n the implementatin f accelerated assessment and cnditinal marketing authrisatin. These are tw key tls in Eurpean legislatin which are intended t accelerate patients access t innvative medicines that target a disease fr which n treatment is available r that prvide patients with a majr therapeutic advantage ver existing treatments. The EMA s accelerated assessment prcedure allws fr a faster assessment f eligible medicines by EMA s scientific cmmittees. Cnditinal marketing authrisatin allws fr the early apprval f a medicine n the basis f less cmplete clinical data than nrmally required, if the medicine addresses an unmet medical need and targets a seriusly debilitating r life-threatening disease, a rare disease r is intended fr use in emergency situatins in respnse t a public health threat. While less cmplete, the available data must still demnstrate that the medicine s benefits utweigh its risks and the applicant shuld be in a psitin t prvide the cmprehensive clinical data after authrisatin within a timeframe agreed with the CHMP. In additin, the benefit t public health must utweigh the risk due t limited availability f clinical data at the time f marketing authrisatin. The main changes in the prpsed revisin t the guideline are as fllws: Accelerated Assessment Mre detailed guidance n hw t justify fulfilment f majr public health interest, which is the basis fr a request fr an accelerated assessment Optimisatin f the assessment timetable by better balancing evaluatin phases t reach a CHMP pinin within the 150 days after the start f marketing authrisatin applicatin prcedure (cmpared t 210 days in nn-accelerated prcedures) Emphasis n the imprtance f early dialgue with EMA s that accelerated assessment can be planned well ahead f the submissin. The EMA highlights that the eligibility criteria laid dwn in the accelerated assessment guideline are als being cnsidered fr a new scheme, currently under develpment, that is designed t facilitate the develpment and accelerated assessment f innvative medicines f majr public health interest, in particular frm the viewpint f therapeutic innvatin. Cnditinal Marketing Authrisatin Page 4 f 5

5 Clarificatin n fulfilment f unmet medical needs, i.e. medicines prviding majr imprvements in patient care ver existing therapies can be legible in certain cases Clarificatin f hw a psitive benefit-risk balance is t be substantiated where there are less cmplete data, with further guidance n the level f evidence that must be prvided at the time f authrisatin and the data that can be prvided after authrisatin Updated guidance n the extent and type f data required t be included in annual renewal submissins. An verview f the prpsed changes is available n the EMA website. Public cnsultatin n the revised guidelines is pen until 30 Sep ail_ jsp&mid=wc0b01ac058004d5c1 Page 5 f 5