International Pharmaceutical Excipients Council ... - IPEC Europe

International Pharmaceutical Excipients Council EuropeNovember 2000IPEC Europe NewsEditorialEditorial…………………………………………….1PharmTech Europe Summit…………………… .2Good Manufacturing Practices…….………….…3The global excipients market (part 1)…………3,4BSE/TSE - The Prion…………………………….5IPEC Europe membership……….……….. .… .5EUFEPS2000…………………………….……..…6IPEC Europe Seminar/AGM 2001………………6,7Calendar of Events…………………. ……………7.******************************************International PharmaceuticalExcipients Council EuropeHenk de JongChairman IPEC EuropeServier (IRIS)6, Place des Pleiades92415 CourbevoieFranceTel +33-1-5572 6178Fax +33-1-5572 7671E-mail: dejong@netgrs.comEvert IzeboudExecutive coordinator to IPEC EuropeKerkweide 272265 DM LeidschendamThe NetherlandsTel +31-70-320 9894Fax +31-70-320 3759E mail: eizeboud@worldonline.nlInternet: http://www.ipec.org/europe.htm**************************************************"Harmoniz(s)ation : It don’t meana thing if it ain’t got that swing"Henk de JongIn October 1991, Lou Blecher, the firstchairman and one of the founding fathers ofIPEC-Americas, wrote in the Vol 1 Number 1Newsletter : “We formed IPEC as a “niche”trade association concerned with andpromoting the interests of bothpharmaceutical (excipient) producers andusers. Our key objective is to foster theinternational harmonization of excipientspecifications, test methods and goodmanufacturing practice requirements inorder to facilitate the free flow of medicinesacross borders”.This statement is still valid in October 2000.Even with more than 200 membersworldwide, we still have a “niche” positionwhen compared to PhRMA, EFPIA andJPMA and we are continuing to fosterharmonization.Harmonization of regulatory requirementswas pioneered by the European Communitysince the creation (1964) of the EuropeanPharmacopoeia and later on the movementto a single market for pharmaceuticals bythe European Commission.A more worldwide approach was initiated bystaff members of the Japanese, UnitedStates and European Pharmacopoeias increating the Pharmacopoeial DiscussionGroup (PDG) in 1989.A little later (1990), a formal cooperationbetween regulators and industryrepresentatives from Europe, USA andJapan was started under the label“International Conference on Harmonizationof Technical Requirements ofPharmaceuticals for Human Use”, in short :“ICH”.( continued on page 2)

International Pharmaceutical Excipients Council Europe_____________________________________________________________(continued from page 1)The first Joint Pharmacopoeial OpenConference on International Harmonizationof Excipient Standards in Orlando, Florida –January 1991, came very timely.Participants realised that because of theirnature (type of manufacturing industry, mainuse usually not in pharmaceuticalformulations) exicipients and their producersrisked being left outside the regulatoryharmonization process. The idea to createIPEC came as a logic step to prevent this.Since 1991, a lot of work has been done,e.g. technical and scientific expertise havebeen provided to the PDG and a number ofmonographs have been “smoothened”,Guidelines for Good ManufacturingPractices based on a universal qualitytemplate (ISO 9002) and PharmaceuticalGMP philosophy were developed andpublished.However, we also learned again that toobtain harmony (from the Greek word forjoining, getting together) is not an easy task.A rethinking of the process, a “fine tuming”of the methods and adjustment of the goalsare necessary while keeping the keyobjective as is.Just before the upcoming 5 th ICHConference (San Diego, November 9-11,2000) delegations from JPEC, IPEC-Americas and IPEC-Europe will meettogether and also with the PDG. We hope torevigorate the pharmacopoeialharmonization process regarding excipientsand also to further develop policy regardingGMP for starting materials. It goes withoutsaying that excipients need a specificapproach because of their diversity, originand uses.From the above, I first want to say thank youto all the individuals and their companies forthe enormous amount of time and energythat has been put into these activities.The good news is : in the future, we willneed more !Firstly, speaking for IPEC-Europe, we willneed, wherever possible, names ofdelegates from each member companyhaving experience (knowledge /responsabilities) in technological (analytical/pharmaceutical), safety or regulatory fieldsregarding excipients. This will allow us torapidly create working teams to answerquestions asked to us (don’t forget we arehighly appreciated as IPEC and consideredas experts in the field by many regulatorsand other scientists) or to help to developpolicy for the Board.Secondly, we will invite a number of topscientists to become members of a ScientificAdvisory Board to IPEC-Europe to help uswith scientific and policy development in thefuture. Informal agreement has already beenobtained from Prof. H. Kristensen(Denmark), Prof. C. Caramella (Italy), Prof.Bolhuis (The Netherlands), Prof. J.R. Claude(France). The size of the Scientific AdvisoryBoard will be around 15 members.Thirdly, we will need volunteers to be activemembers of our committees. As IPEC-Europe members, you have seen a requestfrom our GMP team to have new blood. Irepeat my questions to have 1) commentson the world inventory of excipients, to beadressed to Prof. Pellerin or our coordinatorDr. Izeboud and 2) to have members for thecommittee to develop the inventory.In short, individuals that have the excipient“itch” will know by now that it is not importantto know how to write harmoniz(s)ationbecause like to compensate for the blues inlife, it is much better to remember thefamous jazz title that summarizes everythingreally important in life: “It don’t mean a thingif it ain’t got that swing”PharmTech Summit in ParisOn June 19th and 20th 2000 PharmaceuticalTechnology Europe organized, with supportof IPEC Europe and the UK Institute ofValidation, the PharmTech Europe Summitin Paris. The main theme of this Congresswas Quality Assurance in the manufacture ofactive ingredients and pharmaceuticalexcipients.(continued on page 3)______________________________________________________________________________________November 2000 2 IPEC Europe News________________________________________________________________

International Pharmaceutical Excipients Council Europe_____________________________________________________________(continued from page 3)Excipients are the “unsung heroes” of thedrug world – doing all the work and gettingnone of the glory. However, a number offactors in the market, including the value ofexcipients in extending the patent protectionof drug systems, are helping to move thecontribution of these essential ingredientsinto the limelight.The global excipient marketThe market for excipients is clearly closelyrelated to the market for pharmaceuticals.Recent data published by IMS Healthestimates the global pharmaceutical marketin 1999 to be worth approximately £GB 215billion ($ US 337 billion). The regional splitin sales is shown in Figure 1. Annual growthglobally is estimated at over 7%. NorthAmerica is the largest market and has seenrecent annual growth of 11%. Europe andJapan are the two next largest markets butIMS estimate growth to be under 5% inEurope and sales in Japan have been downin recent years.The growth in healthcare spending in theUnited States is a main driver for the totalpharmaceutical market. Other importantfactors shaping the global pharmaceuticalmarket are the increasing cost of R&Dtogether with shortening product life cyclesand the constantly evolving regulatoryframework.It is difficult to reliably assess data for theexcipients market. A huge variety of marketdata are publicly available, either fromspecialised research firms or from general orchemical/ pharmaceutical press sources, forsales of finished dosage forms by region,country and therapeutic activity. The sameapplies for active ingredients, but gettingaccurate data on volume or value ofexcipient sales on a global basis is not at allstraightforward.The best data, including some multi-clientmarket studies for specific markets (notablyin the USA) and specific dosage forms(notably oral solid dose form), shed somelight on current market behaviour, howeverthere are no readily available globalstatistics on excipient sales. From anexcipient supplier’s point of view theimportant data is related to where themedicines are produced, as this is where theexcipients are sold and used and theinteraction with the customer occurs, butstatistics of sales value of finished productsare of little relevance to them.According to different sources, the estimateof the total value of the excipient market isapproximately £GB 1.5 billion, with anannual growth of 6-8%. This figurerepresents an estimated 600,000 tonnes ofmaterial.The excipient industry is highly fragmentedwith many major players and hundreds ofproducts that have multiple applications. Ingeneral, market trends are the same inEurope and North America but the mainplayers are different. Most manufacturersoffer a range of excipients within a limitedtype of chemistry and no supplier offers thefull range of chemistries. No playercommands more than a 5% marketshare byeither volume or value for the total globalmarket. Higher marketshare is achieved ifdata for specific dosage forms or regions isanalysed.There is in reality no excipients industry assuch. With very limited exceptions, therelevant players in excipients are majorchemical companies that are active in aspecific technology or product chemistry thatserves many different markets. Thepharmaceutical excipients activities of thesecompanies are normally integrated intobroader business units that oftenencompass other applications, for examplethe personal care and food sectors. Usuallythese companies report their annual resultsby still broader categories or consolidateresults for all their markets, thus renderingthe assessment of their performance andmarket position in the global excipientmarket impossible.(continued on page 5)______________________________________________________________________________________November 2000 4 IPEC Europe News________________________________________________________________

International Pharmaceutical Excipients Council Europe_____________________________________________________________EUFEPS 2000Annual General Meeting 2001Evert IzeboudThe Sixth European Congress ofPharmaceutical Sciences was held onSeptember 16-19, 2000 in Budapest,Hungary. This Congress was hosted by theHungarian Pharmaceutical Society. TheChairman, Professor Nyeredi, opened thesymposium by heartily welcoming the 600delegates from 44 countries. The city ofBudapest, split but united into an easternand western part by the river Danube, waschosen as leitmotiv for EUFEPS 2000:bringing together the pharmaceuticalscientists from East and West Europe.The IPEC Europe member companies werewell represented with contributions to theplenary scientific lectures, the poster sessionand the exhibition. Mr Ole Gyllenhaal ofAstraZeneca received a specialacknowledgement for his contribution to theposter session.One of the highlights of EUFEPS 2000 wasthe IPEC Europe symposium (88 attendees)with contributions on the themes regulatoryaspects for new excipients, the BSE/TSEissue and control of the supply chain forpharmaceutical excipients) from respectivelyProfessor Olejniczak (German Government),Dr Agnes Artiges (EDQM), Professor Henkde Jong, Dr Beat Hoernlimann (SwissGovernment), Dr Martijn ten Ham (DutchMinistry of Health) and Mr Olivier Gross(French Government). Summaries of thepresentations have been published on themember area of IPEC Europe's Internet site.IPEC Europe's organising team had aspecial experience in making the symposiuma success. Henk de Jong compared theefforts with running an Olympic hurdle race.But also here the adagium "It is the resultwhich counts" proved to be valid.The 7th EUFEPS Congress will beorganised in Stockholm (Sweden) in 2002.The IPEC Europe Board has decided thatIPEC Europe again will give "acte depresence".Preliminary Program IPEC Europe SeminarLe Plaza BrusselsJanuary 25th 2001, 10.00 AM-16.00 PM1. Welcome and introductionMr Henk de Jong(Servier, Chair of IPEC Europe)10.30-10.452. Certification Procedure EDQMSpeaker confirmed(EDQM, Certification Department,10.45-11.153. Certification ProcedureTSE compliance-a case studyMr Louis van Dederen (Uniqema)11.15-11.45Discussion-----------------------------LUNCH 12.30-14.00-----------------------------4. GMP for starting materials forpharmaceutical products.(to be confirmed)14.00-14.305. GMP for pharmaceutical excipientsMr Steve Moss (Glaxo Wellcome)Pharmaceutical Quality Group,( to be confirmed)14.30-15.006. GMP Inspections in FranceMr Olivier Gross (AFSAPPS)15.00-15.30Discussion(continued on page 7)______________________________________________________________________________________November 2000 6 IPEC Europe News________________________________________________________________

International Pharmaceutical Excipients Council Europe_____________________________________________________________(continued from page 6)Annual General Meeting BrusselsJanuary 25th and 26th 2001Meetings, Symposia and SeminarsCalendar 2000/2001Second AnnouncementNovember 6th!4.00-18.00 PMBoard Meeting,Hilton Hotel,Milan, Italy.It has become a well appreciated tradition toorganize the Annual Meeting of IPECEurope in the month of January. Due to thesuccess in both 1999 and 2000 the Boardhas decided to continue organising a "hottopic" seminar on the day preceeding theAnnual General Meeting (see page 6 of thisNewsletter).For the first time in its 9 year existence asocial event (evening dinner) will beorganised for the representatives of theIPEC Europe membership, attending theSeminar and the Annual General Meeting.Both events will be organized in the famousHotel Le Plaza in the centre of Brussels.Transport (by bus) will be arranged forparticipants arriving in the morning ofJanuary 25th 2001 at Brussels ZavetemAirport. Details on the IPEC Europe events,including the agenda, will be communicatedby IPEC Europe e-mail circular.IPEC Europe members intending to attendthis free symposium and subsequently theAnnual General meeting are invited to informMr Izeboud by e-mail or fax:November 6th- 7th,9.00 – 17.00IPEC World MeetingMeeting with PDGSan Diego U.S.A.November 7th- 9th, CphI 2000,Fiera MilanoMilan, Italy.December 6thJanuary 25th 200110.00 AM-16.00 PMJanuary 25th 200116.00 PM-19.00 PMJanuary 26th 200109.00 AM-16.00 PMManagement ForumLondonProgramLondon, UnitedKingdom.IPEC EuropeSeminarThe Plaza, BrusselsIPEC EuropeBoard MeetingThe Plaza, BrusselsIPEC EuropeAnnual MeetingThe Plaza, BrusselsFor a complete overview of future meetingsof the IPEC Europe Board and - Committeesyou have to consult the "Meetings &Seminars" page of the Internet Site of IPECEurope.Evert IzeboudExecutive co-ordinator to IPEC EuropeTel +31-70-320 9894Fax +31-70-320 3759E mail : eizeboud@worldonline.nlNewsletter 1st issue 2001The next Newsletter is scheduled to beissued during the Annual General Meeting2001 in Brussels, Belgium. IPEC Europemembers who would like to contribute to thethis issue are invited to submit textelectronically (maximum 1 A4) to MrIzeboud. Deadline: January 7th 2001.______________________________________________________________________________________November 2000 7 IPEC Europe News________________________________________________________________

International Pharmaceutical Excipients Council Europe_____________________________________________________________CPhI 2000 ExhibitionIPEC Europe at the CPhI 2000!Milan, November 7-9 , 2000For detailed information about IPECEurope's activities, you are invited to visit theIPEC Europe stand which is located in Hall14/1, standnumber F 401.The main theme of the IPEC Europe CphI2000 display will be dedicated to theControl of the Supply Chain ofpharmaceutical excipients throughimplementing the IPEC principles of GoodManufacturing Practices (both formanufacturers and distributors).Available at the stand are the most importantpublications of IPEC Europe dealing withGood Manufacturing Practices ofpharmaceutical excipients.IPEC EuropeE. Izeboud27 Kerkweide2265 DM LeidschendamThe NetherlandsTel +31-70-320 9894Fax+31-70-320 3759E-mail eizeboud@worldonline.nlInternet: http://www.ipec.org/europe.htm______________________________________________________________________________________November 2000 8 IPEC Europe News________________________________________________________________