R and D 47 - cirsci.org

R&D Briefing

50

A cross-regional comparison of the regulatory environment in emerging markets

A discussion of the regulatory issues in the emergingmarkets and the impact on patients’ access to newmedicines, with reference to a three-region study carriedout by CMR International

Key points 1

Introduction 2

Different regions but similar issues 3

Regulatory agencies: Cross-regional perspectives 4

The Issues: Review processes and timelines 5

The Issues: Both sides of the fence 6

The Industry: Cross-regional perspectives 8

Performance ratings: An Industry view 9

Glossary 9

Institute for Regulatory Science

Authors

Neil McAuslane

Margaret Cone

Jennifer Collins

February 2006

Further information on Institute Activities

For information on forthcoming Workshops and current and future studies and publications visit the website:www.cmr.org/institute

The Institute programme of activities is published in the Institute Agenda, available from the website

CMR International Institute for Regulatory Science Novellus Court 61 South Street Epsom Surrey KT18 7PX UK Tel: +44 (0)1372 846 100 Fax: +44 (0)1372 846 101 Email: [email protected]

CMR International Institute for Regulatory Science

The CMR International Institute forRegulatory Science is a not-for-profitdivision of the Centre for MedicinesResearch International Ltd. It worksin the regulatory and policy arenaand in close association with theresearch-based pharmaceuticalindustry and regulatory authoritiesaround the world.

The Institute operates autonomouslywith its own dedicated managementand funding that is provided byincome from a membership scheme.The Institute for Regulatory Sciencehas a distinct agenda dealing withregulatory affairs and their scientificbasis, which is supported by anindependent Advisory Board ofregulatory experts (see back cover)

1

A cross-regional comparison of the regulatoryenvironment in emerging markets

Key points

The emerging markets of Asia-Pacific, the Middle East, Africa and LatinAmerica are becoming increasingly important to pharmaceutical companies intheir global strategies for the registration of new medicines and making themavailable to patients worldwide.

A major study has been carried out by CMR International that looked atregulatory practices and procedures in these emerging markets from both anagency and industry viewpoint. For the purpose of the study, the countrieswere divided into three regions:

• South East Asia and the Western Pacific• The Middle East and Africa• Latin America

The main objective was to identify factors that facilitate or impede the efficientregistration of new medicines and their timely access to patients.

At a regional level, this study revealed many interesting similarities anddifferences between neighbouring countries and these have been reportedseparately1. When the three regions are compared and a cross-regional view istaken, however, one conclusion becomes evident:

Notwithstanding the apparent differences and diversity between the regions,the regulatory aspirations, barriers, problems and priorities, related to thereview and availability of new medicines, are essentially similar.

This Briefing is intended as a background document to encourage discussion ofthe key issues among and between regulatory agencies and companies. Theseinclude:

• Ways to improve the efficiency and timeliness of the regulatory reviewprocess for new medicines;• Best practices for integrating product certification (the CPP) into theapproval process;• The mutual benefits of good communications and transparency inregulatory processes.

1ReferencesAssessing the regulatory environment and its impact on patients’ access to new medicines

R&D Briefing 47: South East Asia and the Western Pacific

R&D Briefing 48: The Middle East and Africa

R&D Briefing 49: Latin America

Published by CMR International Institute for Regulatory Science. Available on request from

[email protected] or via the website: www.cmr.org/institute

A discussion of the regulatory issues in the emerging markets and the impact on patients’ access tonew medicines, with reference to a three-region study carried out by CMR International.

www.cmr.org/institute

2

Introduction


Emerging Markets

All the major markets for new medicines have been through an ‘emerging market’ stage and their regulatoryagencies have had to learn new skills and adopt new procedures in order to keep abreast of technological advances.

The USA and Western Europe were the emerging markets for introduction of synthetic molecules as ‘new drugs’ inthe pharmacological revolution of the 1950s and 1960s. The fast-growing research-based pharmaceutical companiesof the day had their headquarters in the US and Europe but were soon joined by major Japanese enterprises as themarket in Japan expanded to meet patients’ demand for access to new medicines.

By the 1990s the development and regulation of new active substances (NASs)was dominated by the USA, EU and Japan, which have become known as thethree ‘ICH regions’ as a result of a major international initiative, theInternational Conference on Harmonisation1 In the late 1990s, however, andincreasingly in the first years of this century attention has turned to theemerging pharmaceutical markets in other regions of the world.

The global industry

Pharmaceutical companies are now focusing on ‘global drug development’ andlooking at the rapidly expanding markets in the Asia-Pacific, Latin American,African and the Middle East regions. Companies are not only seeking to maketheir products available to patients in these ‘emerging markets’ but also toincorporate, into their worldwide clinical development strategies, those newlyindustrialising countries that have a sufficiently advanced clinicalinfrastructure.

A new regulatory environment

Meanwhile, the regulatory agencies in the emerging markets have beenchanging and evolving. Some have developed in partnership with, andfollowing good practice guidelines established by, the agencies in the US, EUand Japan as well as Canada, Australia and Switzerland. The World HealthOrganization has also been active, since the early 1970s, in providing guidanceand assistance to regulatory agencies in all the so-called ‘developing countries’.

Regional harmonisation initiatives (Table 1) and increasing awareness of the role of ICH through membership of theGlobal Cooperation Group (GCG)1 have also played a part in encouraging the development of regulatory agenciesby improving communications and fostering a better knowledge and mutual understanding.

Patient access to medicines

Patients in all regions of the world arebecoming increasingly aware of medicalinnovations and expect timely access tonew medicines.

There are, however, many factors that canhave an impact on such access. One is the‘lag’ time, which may be two or more years,between products being approved in theICH regions and submitted for registrationin the emerging markets. Another is thecompanies’ perception of the localregulatory environment when prioritisingtheir regulatory strategy.

Once applications are made, the decisionon whether the new product should beapproved and made available in thecountry may not be made on a scientificevaluation of safety, quality and efficacyalone. Figure 1, indicates some otherfactors that can influence regulatoryoutcomes.

1 See Glossary, page 9

Approval in a reference country

National drug policy

Drug pricing

Cost benefit / cost effectiveness

Clinical ‘need’

Benefit / risk assessment

Figure 1

(n)= number of agencies that provided dataPercentage of regulatory authorities

Asia-Pacific (n=9) ME and Africa (n=9) Latin America (n=6)

Factors other than safety, quality and efficacy that can influence decisions to approve a marketing application

0 20 40 60 80 100

Regional Harmonisation Initiatives

The ASEAN Pharmaceutical - ProductWorking Group (P-PWG ) is developingharmonised guidelines for the regulation ofpharmaceuticals, including the ASEAN CTD.

APEC, (Asia-Pacific Economic Cooperation)has set up harmonisation initiatives throughthe APEC Network of PharmaceuticalScience

The Gulf Cooperation Council (GCC) hasestablished a centralised procedure for theregistration of NASs in the Arab States ofthe Gulf.

PANDRA, the Pan-American Network forDrug Regulatory Harmonization has beenestablished by the Pan-American HealthOrganization/WHO Regional Office for theAmericas (PAHO/AMRO).

SADC: The Southern African DevelopmentCommunity’s Pharmaceutical Programmehas regulatory harmonisation within itsmandate.

Table 1

3

Different regions but similar issues


CMR International Study

The data used to illustrate the points madein this briefing were collected in a majorstudy carried out by the CMR InternationalInstitute for Regulatory Science in 2004.The study covered thirty countries in threegeographical regions (see Table 2) andinvolved ten pharmaceutical companiesthat were actively marketing newmedicines in one or more of the threeregions.

One of the major ‘messages’ to emergefrom this study was that, notwithstandingthe diversity of the different regions thatwere studied, the priority issues forimproving the registration process for newmedicines were essentially similar

Both companies and agencies were askedsimilar questions about the hurdles in the wayof efficient registration of new medicines andtimely access of new medicines to patients.

The similarities were more pronounced in theresponses from companies (Figure 2) thanamong the regulatory agencies (Figure 3).

Not unexpectedly, both companies andauthorities identified the lack of resourcesavailable to the government agencies as animportant impediment to the registration ofnew medicines (although the authorities inLatin America were less concerned about hisaspect).

Ways to ensure that valuable but limitedresources are used to best advantage areamong the items discussed further in thisbriefing.

Major areas of concern as seen by industry: Factors relating to Authorities’procedures that delay applications and approvals of NASs

Relative importance

0% 20% 40% 60% 80% 100%

Figure 2

Countries included in the CMR International Institute Study

China* (9)Hong Kong (9)India (8)Indonesia (9)Malaysia (8)Philippines (9)

Singapore (9)South Korea (9)Taiwan (8)Thailand (9)Vietnam* (8)

Bahrain (9)Egypt (9)Jordan (9)Kenya (7)Kuwait (9)Morocco* (6)

Nigeria* (6)Oman (8)Saudi Arabia (9)South Africa (8)Turkey* (7)UAE (9)

Argentina (7)Brazil (7)Chile (7)Colombia* (7)

Costa Rica (7)Mexico (7)Venezuela (7)

South East Asia and West Pacific Middle East and Africa Latin America

(n)= Number of participating companies in the country * Data obtained only from companies operating in the country and not from the local agency

Asia-Pacific ME and Africa Latin America

Major areas of concern as seen by agencies: Internal and externalfactors that delay reviews and patient access to NASs

Percentage of regulatory agencies in each region

0% 20% 40% 60% 80% 100%

Figure 3

Asia-Pacific ME and Africa Latin America

Timing of the CPP

Regulatory approval times

Level of transparency

Staff: Lack of technical expertise

Staff: Lack of electronic support

Harmonisation issues

Intellectual property protection

Pricing requirements

Analysis of samples

Need for local trials

Lack of internal resources

Insufficient internal IT resources

Lack of experienced reviewers

Poor company communications

Delay from first global submission

Industry lack of understanding

Table 2

Authority data from the CMR International Study

Review process and data requirements

Previous registration is essential for authorisation

Previous registration is not always a pre-requisite

ICH CTD format is not accepted (a)

All ICH guidelines are accepted

Selected ICH guidelines only are accepted

Certificate of a Pharmaceutical Product (CPP)

CPP is required with application

CPP accepted later but prior to approval

Legalisation of CPP required by Embassy

Other policy and procedural issues

IP protection laws implemented (d)

Pricing is part of approval

Local clinical trials required for registration

4

Regulatory agencies: Cross-regional perspectives

The regulatory agencies that participated in the CMR International Study provide a wide spectrum of regulatoryphilosophies and review practices.

Singapore

“… contribute to the development of the biomedicalsciences by administering a robust, scientific andresponsive regulatory framework …”

India

“…to provide an enabling environment for introductionof new medicinal products of proven safety andefficacy…”

Costa Rica

“…by using Governance, with full involvement of socialstakeholders to contribute to maintaining and improvingquality of life among the population…”

South Africa

“…To safeguard public health through timely access toquality medicines. … To have a transparent andaccountable regulatory authority. …”

Extracts from authority mission statements


■ Full reviews: Some agencies, e.g., Brazil, Singapore,South Korea, South Africa and Taiwan are establishingthe internal resources and expertise to carry out fullreviews of NAS application data.

■ CPP: The Certificate of a Pharmaceutical Product isessential for the registration of products in the largemajority of countries with many requiring this to beavailable before an application is made.

■ Pricing: The price of new products must be negotiatedas part of the approval process in many of the MiddleEast countries.

■ Future objectives: Several authorities, includingArgentina, Brazil, Chile, Egypt, India, Malaysia,Singapore, South Korea, Taiwan and Thailand listedencouraging local clinical development among thefuture goals for the country

Table 3 provides an extract of the responses from the authorities to questions on key aspects of their procedures.

Ho

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*= No responsea: The ASEAN CTD may replace the ICH CTD in ASEAN countriesb: ICH is not implemented in Egyptc: CPP not essential in South Africa but, if available, must be submitted withthe application

d: Intellectual property protection to meet TRIPs requirements (see page 9)e: IP protection implemented after the surveyf: Requirement for CTs may depend on the type or regulatory status of product

Table 3 Asia-Pacific Middle East and Africa Latin America

5

The Issues: Review processes and timelines

A major factor in the timely access of new medicines to patients is the time taken by national regulatory authoritiesfor the review and approval of applications. This is, of course, also a major preoccupation for pharmaceuticalcompanies when planning their global registration strategies for innovative new medicines. Figure 4 gives therange of regulatory approval times in different countries, based on data provided for the NAS applications includedin the CMR International study.

Regulatory approval times (from date of submission to date of marketing approval) for NASs submitted and approved between 2001 and 2003

1000

900

800

700

600

500

400

300

200

100

0

Ho

ng

Ko

ng

(27

)

Ind

ia (

11)

Ind

on

esia

(16

)

Mal

aysi

a (1

2)

Phili

pp

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(23

)

Sin

gap

ore

(28

)

Sou

th K

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a (1

4)

Taiw

an (

15)

Thai

lan

d (

16)

Vie

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(19

)

Bah

rain

(11

)

Jord

an (

13)

Ken

ya (

7)

Ku

wai

t (1

1)

Mo

rocc

o (

7)

Nig

eria

(8)

Om

an (

6)

Sau

di A

rab

ia (

11)

Sou

th A

fric

a (8

)

Turk

ey (

7)

UA

E (9

)

Arg

enti

na

(22)

Bra

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16)

Ch

ile (

16)

Co

lom

bia

(20

)

Co

sta

Ric

a (2

3)

Mex

ico

(15

)

Ven

ezu

ela

(18)

1 Regional median approval times for Asia-Pacific: 282 days, and ME-Africa: 283 days2 Regional median approval times for Latin America: 175 days


Figure 4

Practices that can impact on review times

Factors that speed Factors that impede

■ Setting target times and deadlines for differentstages of the review e.g.- Validation - Scientific Review - Company responses to questions■ Implementing management systems for monitoringtimelines and work flow■ Establishing service level agreements with outsideassessors to ensure that deadlines are respected■ Providing facilities for companies to discusssubmissions before and during the review process■ Seeking opportunities to provide trainingprogrammes and incentives for agency staff

■ Reviewing different sections of the application(quality, safety, efficacy data) in sequence rather thanin parallel■ Sending major questions to companies ad hocthroughout the assessment of the application andasking for extra data late in the review process■ Allowing analytical work on samples to become atime-limiting step in the authorisation process■ Including price negotiations as part of the regulatoryreview process rather than assessing applications onsafety, quality and efficacy alone■ Expecting staff to work efficiently with inadequateresources and IT facilities

Tim

e (d

ays)

Country

Asia-Pacific Middle East and Africa Latin America

Data are shown for NASs that were submitted and approved between 1 January 2001 and 31 December 2003. (n)= number of NAS. Box: 25th and 75th percentiles. Whiskers 5th and 95th percentiles. Diamond = median

1

2

6

The Issues: Both sides of the fence


Company perspective

Timing of the CPP: If authoritiesinsist on receiving the CPP at thetime that an application for a newmedicine is made, the companycannot start the application processuntil an authorisation has beengranted elsewhere. Sinceregistration in the first market (e.g.,EU or USA) can take up to 18months, registration in the newmarket will be significantly delayed.

Source of the CPP: Some agenciesrequire the CPP to be issued by theauthority in the ‘country of origin’(manufacture). In today’senvironment, however themanufacturing site(s) for a NAS maynot be in a country where theauthority carried out the primaryreview. Companies feel that a singleCPP from a major reference agencysuch as FDA, EMEA, PMDA shouldsuffice, provided that GMPcertification for the actualmanufacturing site is included.

Legalisation: Some agencies (seeTable 3) still require legalisation ofthe CPP by the local Embassy orConsulate rather thanauthentication by the regulatoryagency issuing the certificate. Thisbuilds additional delays into thesubmission process.

The Certification Scheme

The WHO Certification Scheme onthe Quality of Products moving inInternational Commerce wasoriginally set up primarily to helpregulatory authorities obtaininformation on the GMP status ofimported products. In 1988 theScheme was extended to includeproduct information and theregulatory status.

The Certificate of a PharmaceuticalProduct (CPP) is issued by aregulatory authority that hasauthorised the product for nationalsale or for export to the authority inthe importing country. The CPPcertifies that the product ismanufactured under GMPconditions and gives information onthe terms of the marketingauthorisation.

Authority perspective

Timing of the CPP: Receipt of theCPP with the application ensuresthat the product has been reviewedand approved by a recognisedregulatory agency. In the absence ofthis assurance, time and effort couldbe spent on processing anapplication for a product thatultimately fails to gain approval inits primary market.

Smaller agencies often rely on theCPP rather than carrying out theirown full scientific review of NASs. Itcan therefore seem illogical toargue that the CPP need not beincluded at the time of making theapplication.

A number of agencies are, however,prepared to be flexible and willaccept applications and start thereview process before the formalCPP documentation is available.

Legalisation: The need for anEmbassy or Consulate toauthenticate the CPP is often astatutory requirement outside theremit of the agency.

Company perspective

Experience has shown the valueand benefits of an open andtransparent relationship betweencompanies and regulatoryauthorities. A good regulatoryenvironment is an important factorin encouraging early registration ofnew medicines.

Consultation before implementingnew regulations or guidelines isalso an important part of the‘partnership’ with industry thatprovides valuable benefits and anadditional resource for theauthorities.

Elements of Transparency

■ Published information on thereview process and company accessto advice from authorities beforesubmitting an application

■ Secure company access to thestatus of applications oncesubmitted

■ The ability to meet agency staffto discuss technical and proceduralissues when problems arise

■ Agency accountability for thespeed and quality of reviews

■ Clear communication throughoutthe review process


Providing facilities forcommunication and interactionwith companies and access tosecure electronic applicationtracking systems may be difficult tojustify when resources are limited.

When agencies do establish ‘opendoor’ policies they expectcompanies to respect the privilegeand ensure that staff and expertswill not be subjected to excessivedemands on their time.

TRANSPARENCY OF THE REVIEW PROCESS AND COMMUNICATION WITH REGULATORY AGENCIES

THE CERTIFICATION SCHEME AND CERTIFICATE OF A PHARMACEUTICAL PRODUCT (CPP)

7

The Issues: Both sides of the fence

Co ntr


Company perspective

History has shown that a lack ofharmonisation can lead tounnecessary duplication of effort.Unless there is a sound scientificjustification and rationale, theneed to carry out additional oralternative testing to meet localguidelines is regarded as a waste ofvaluable resources.

Such requirements may act as adeterrent to the early registrationof valuable new medicines, in theemerging markets.

The Issues

The large majority of NASs arecurrently developed in the threeICH regions and tested according toICH guidelines1. Similarly, thesupporting data for theseapplications will have beenassembled in the ICH CTD format.

Many regional harmonisationinitiatives (Table 1, page 2) areprimarily concerned with theregistration of generic productsalthough the GCC initiative and thedevelopment of an ASEAN CTDhave implications for NASapplications.


ICH guidelines were not developedwith the local conditions of theemerging markets in mind. Anexample is the climatic conditionscovered in the Stability Guidelines.

Many authorities are, however,prepared to be flexible in acceptingdata and information on NASs thathas been generated according toICH norms.

HARMONISATION OF TECHNICAL REQUIREMENTS FOR NASs

MULTIPLE INSPECTIONS OF MANUFACTURING SITES

INTELLECTUAL PROPERTY PROTECTION

Company perspective

Multinational companies oftensource products from severaldifferent manufacturing sites. The companies themselves carryout inspections and audits toconfirm that all sites meet GMPstandards and validate productsfrom different sites to ensure theyare interchangeable.

Whilst expecting to be inspected bythe authority through which theproduct is first registered (normallyFDA, EMEA or PMDA) they believethat GMP certification from a majorauthority should subsequently berecognised and accepted by otheragencies.

The Issues

There are concerns about theresource implications for bothagencies and companies whenmultiple inspections are carried outby different authorities.


Few of the authorities in theemerging markets have mutualrecognition agreements (MRAs)with other countries for theinspection of pharmaceuticalmanufacturers.

Although concerns about poorquality and substandard productsdo not relate primarily to NASsfrom multinational companies, therequirement for GMP inspectionsfor imported products is often alegal requirement or a question ofgovernment policy.

Company perspective

Companies need to be confidentthat technical data submitted toregulatory agencies will remainconfidential and that IP legislationwill protect patent violations andthe marketing of pirated products.

Deficiencies in IP protection aremajor disincentives to companiesplanning the registration ofproducts in new markets.

The Issues

Adequate and enforceableprotection of IP rights is regarded asa cornerstone for current andfuture investment in newmedicines.

This was recognised in the adoptionof the TRIPS agreement1 to whichthe large majority of emergingmarket countries are signatories


Regulatory agencies accept theirresponsibilities for safeguarding theconfidentiality of the data insubmissions.

The enforcement of patent andother IP legislation, however, isoften outside the remit of theregulatory agencies.


8

The Industry: Cross-regional perspective

Multinational companies

The participating companies in theCMR International Study areresearch-based firms involved inworldwide R&D and marketing ofinnovative new medicines.

There is a range of experienceamong these companies, whenlooking at the time they have beenoperating in the different countries(Figure 5). Companies have beenestablished longest, many over 50years, in the Latin Americancountries, India, Taiwan and SouthAfrica. Companies have leastexperience in Vietnam, China,Nigeria and Turkey.

There are marked regionaldifferences in the way in which thecompanies are represented atcountry level. In Asia-Pacific andLatin America, the majority haveestablished local subsidiaries whilstin the Gulf States and Jordan, it ismuch more common for companiesto act through a local agent,although this is not the case inEgypt and the countries studied inAfrica.

An area of concern identified by theregulators (Figure 3, page 3) waspoor communications withincompanies (i.e. between local leveland headquarters). Interestingly thisis perceived as a greater problem inAsia-Pacific, where subsidiaries arethe norm, than in the Middle East-African region where much of thecommunications is via agents.


New Active Substances

The CMR International Study, asnoted, focused on the submissionand registration of new activesubstances1 and collected data onsubmissions made between January2001 and December 2003. Figure 6gives a comparison of the numberof NAS applications made in thedifferent countries.

Length of time companies have been operating in the three Regions

China

Hong Kong

India

Indonesia

Malaysia

Philippines

Singapore

South Korea

Taiwan

Thailand

Vietnam

Bahrain

Egypt

Jordan

Kenya

Kuwait

Morocco

Nigeria

Oman

Saudi Arabia

South Africa

Turkey

UAE

Argentina

Brazil

Chile

Colombia

Costa Rica

Mexico

Venezuela

Figure 5

Number of companies

Asia-Pacific Middle East and Africa Latin America

Co

un

try

0 1 2 3 4 5 6 7 8 9 10

< 10 years10 to 50 years> 50 years

Number of New Active Substances submitted for the first time during 2001-2003

Figure 6

Nu

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f N

ASs

Country

Ch

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Ho

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Ko

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Ind

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Ind

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Taiw

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Bah

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9

Performance ratings: An industry view

The CMR International study asked companies for their views and opinions on many of the issues that may have animpact not only on the successful registration of new medicines but also on decisions about priorities for theregistration of new medicines in their global regulatory strategy. Whilst it is recognised that opinions may besubjective and influenced by specific events, we nonetheless present the following ‘Award’ table based oncompanies’ perception of regulatory performance.


Accolade Country Score Accolade Country Score

VietnamBahrainMexico

IndonesiaKuwait and UAEBrazil

SingaporeNigeriaArgentina

IndiaKuwait and UAEArgentina

156 days87 days101 days

7/9 companies5/8 companies4/6 companies


5/7 companies 6/8 companies 4/6 companies

HarmonisationGuidelines harmonisedwith ICH and/or WHOguidance

Lack of local biasImported and localproducts treatedequally

IP and data protection Not a problem in thecountry

Clinical trialsNo barriers toconducting local trials

Hong KongOman and UAEArgentina

Hong KongKenyaColombia

SingaporeJordan

MalaysiaKuwaitChile

6/9 companies7/7 & 6/6 companies4/7 companies


6/8 companies5/7 companies


Shortest review timesMedian review timescalculated on NASssubmitted 2001-2003

Pre-submission adviceContact encouraged,good relationshipsestablished

TransparencyFeedback duringreview: Process ratedas ‘transparent’.

Quality of adviceRated as Excellent orGood

GlossaryNew Active Substance (NAS) TRIPS

For the purpose of the CMR InternationalSurvey NASs were defined as a chemical,biological, biotech or radiopharmaceuticalsubstance that has not been previouslyavailable for therapeutic use in humansand is destined to be made available as a‘prescription only medicine’, to be used forthe cure, alleviation, treatment, preventionor in vivo diagnosis of diseases in humans

The World Trade Organization’s (WTO) Agreement on Trade-RelatedAspects of Intellectual Property Rights (TRIPS) covers a wide range ofIP-related subjects including patents, copyright and trademarks andtrade secrets. TRIPS sets minimum standards of intellectual propertyprotection that WTO Members must provide. Members designated as‘developing countries’ had until 2000 to implement the agreementand least developed countries had until 2006.A Fact sheet on TRIPS and pharmaceutical patents is available via theWTO website: http://www.wto.org

ICH: International Conference on the Harmonisation of Technical Requirement for the Registration of Pharmaceutical Products for Human Use.

ICH brings together the regulatoryauthorities of the EU, Japan and theUnited States (with observers fromCanada, Switzerland and WHO) andexperts from the pharmaceuticalindustry in the three regions todiscuss scientific and technicalaspects of product registration.

Common Technical Document (CTD)ICH has established a commonformat for regulatory submissionssetting out the order and structurefor reporting the scientific data thatsupports a marketing application fora NAS.

ICH guidelines, agreed through theharmonisation process andimplemented by the regulatorybodies, cover the development ofNASs and requirements for testingand monitoring their safety, qualityand efficacy. Over 50 have beenadopted.

Global Cooperation Group (GCG)

This was set up in 1999, as a subcommittee of the ICH Steering Committee. Its purpose is to make information onICH widely available among agencies and companies worldwide. The regional, organisations involved in regulatoryharmonisation outside the ICH regions (see Table 1, page 2) have been invited to designate permanentrepresentatives to the GCG.

CMR International Institute for Regulatory Science

CMR International Institute for Regulatory ScienceNovellus Court, 61 South Street, Epsom, Surrey KT18 7PX, UKTel: +44 (0) 1372 846 100 Fax: +44 (0) 1372 846 101 E-mail: [email protected], Web: www.cmr.org/institute

Prof. Robert Peterson (Chairman), Professor of Paediatrics, University of British Colombia Canada

Prof. Sir Alasdair Breckenridge (Vice-Chairman), Chairman, Medicines and Healthcare products Regulatory Agency (MHRA) UK

Prof. Gunnar Alván, Director General, Medical Products Agency Sweden

Omar Boudreau, Director General, Therapeutic Products Agency Canada

Dr. Osamu Doi, Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) Japan

Prof. Bruno Flamion, Chairman, EMEA Scientific Advice Working Party Belgium

Dr Leonie Hunt, Director Drug Safety and Evaluation Branch, Therapeutic Goods Administration Australia

Dr John Jenkins, Director, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and USA

Drug Administration

Dr Murray Lumpkin, Deputy Commissioner, International and Special Programs, Food and Drug Administration USA

Thomas Lönngren, Executive Director, European Medicines Agency (EMEA) EU

Franz Schneller, Executive Director, Swissmedic Switzerland

Dr Graham Burton, Senior Vice President, Regulatory Affairs, Pharmacovigilance and Project Management, Celgene Corporation USA

Dr Michael Doherty, Global Head of Pharma Regulatory Affairs, F Hoffmann-La Roche Ltd Switzerland

Dr Tim Franson, Vice President, Global Regulatory Affairs, Lilly Research Laboratories USA

Dr Stewart Geary, Deputy Director, Corporate, Regulatory Compliance and Quality Assurance Headquarters, Eisai Co. Ltd. Japan

Dr Edmund Harrigan, Senior Vice President, Worldwide Regulatory Affairs, Pfizer Inc. USA

Dr Paul Huckle, Senior Vice President, US Regulatory Affairs, GlaxoSmithKline R&D Ltd USA

Dr Brian White-Guay, Vice President, Head of MRL Transformation Task Force, Merck & Co. Inc. USA

Prof. Stuart Walker, President and Founder of CMR International UK

Members of the Regulations Advisory Board (2005)

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