POLICY & REGULATORY ENGAGEMENT
Embarking into Phase 2 of the National Biotechnology Policy (NBP), BiotechCorp continues its active role in supporting the formulation of a progressive regulatory agenda for the biotechnology sector in accordance with Thrust 7 of the NBP which emphasises the importance of establishing a solid, balanced and supportive regulatory framework for the development of biotechnology in Malaysia. Continuous engagement with all relevant regulatory authorities is necessary to ensure that the foundation laid down during Phase 1 of the NBP in creating a conducive regulatory environment will be further enhanced to support the commercialisation phase of the NBP.
Focus Areas:
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2011
Operational Review
Key Results
Biosafety Framework t 5IF#JPTBGFUZ "QQSPWBMBOE/PUJGJDBUJPOT3FHVMBUJPOTDBNFJOUP GPSDFJO/PWFNCFSXIFSFCZEFUBJMFEQSPDFEVSFTBOEHVJEFMJOFTJO regulating activities involving Living Modified Organisms (LMOs) were established.
t *OUIFOFXMZNJOUFE#JPTBGFUZ3FHVMBUJPOTXFSFQVUUPQSBDUJDF through applications for approvals and also notifications by the industry and research fraternity.
tBiotechCorp continued to provide regulatory advisory support for the industry and also investors in submitting biosafety applications/
notifications.
tBiotechCorp also provided strategic input to the Ministry of Natural 3FTPVSDFT BOE &OWJSPONFOU PO UIF HPWFSONFOU DPNNJUNFOU UP UIF i/BHPZB o ,VBMB -VNQVS 4VQQMFNFOUBSZ 1SPUPDPM PO -JBCJMJUZ BOE 3FESFTTwUPUIF$BSUBHFOB1SPUPDPMPO#JPTBGFUZXIJDIXBTBEPQUFE
Issue / Activity Results
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#JPMPHJDBM%JWFSTJUZw5IF/BHPZB1SPUPDPMJTBOJOUFSOBUJPOBMBHSFFNFOU which aims at sharing the benefits arising from the utilisation of genetic SFTPVSDFT JO B GBJS BOE FRVJUBCMF XBZ JODMVEJOH CZ BQQSPQSJBUF access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components.
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*OUFMMFDUVBM1SPQFSUZ *1 #JPUFDI$PSQDPOUJOVFTUPXPSLUPXBSETTUSFOHUIFOJOHUIF*1GSBNFXPSL in Malaysia through the following measures:
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TIF*OUFMMFDUVBM1SPQFSUZ$PSQPSBUJPOPG.BMBZTJB .Z*10FBSMZUIJTZFBS introduced formal provisions for expedition of examination for patent and trademark applications through amendments to the Patents 3FHVMBUJPOTBOE5SBEF.BSLT3FHVMBUJPOTWJBUIF1BUFOUT "NFOENFOU 3FHVMBUJPOT BOE 5SBEF .BSLT "NFOENFOU 3FHVMBUJPOT 5IJT DBNF JOUP GPSDF PO 'FCSVBSZ
#JPUFDI$PSQDPOUJOVFTUPGVOEQBUFOUFYBNJOFSTPODPOUSBDUCBTJT JOUPBTTJTU.Z*10JOSFEVDJOHQBUFOUQFOEFODZBOEUPFOTVSF that the target timelines as introduced in the new regulations are met to support and spur the creation of more innovations.
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BiotechCorp cPOUJOVFT JUT FOHBHFNFOU XJUI .Z*10 XJUI SFHBSET UP BNFOENFOUT UP UIF 1BUFOUT "DU QBSUJDVMBSMZ JO SFMBUJPO UP provisions relating to biotechnology inventions as they are being drafted. BiotechCorp anticipates that the proposed amendments will CFQVUGPSUIGPSTUBLFIPMEFSTDPOTVMUBUJPOJOFBSMZCFGPSFCFJOH tabled in Parliament.
Issue / Activity Results
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A National Seminar on the Budapest Treaty was jointly organised by MyIPO in collaboration with the World Intellectual Property Organisation (WIPO) in September to create awareness among stakeholders on the workings and operations of the Budapest Treaty.
BiotechCorp remains engaged with MyIPO in its efforts for Malaysia to accede to the Budapest Treaty.
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Various capacity building initiatives were also carried throughout the year including workshops and regulatory updates for internal and external customers.
Issue / Activity Results
In 2011, BiotechCorp participated in the Technical Working Group (TWG) for pharmaceutical, traditional medicines & health supplements and medical devices and provided industry input for the harmonisation of regulations in the three sectors in ASEAN. Through the ASEAN Consultative Committee in Safety and Quality (ACCSQ) Product Working Group (PWG) participation, we were able to keep track on the work programme progress and the time frame targeted in harmonising standards and reducing technical barriers towards a single market by 2015.
International Accreditation
(GLP) Pharma Regulations
In relation to GLP, Malaysia’s efforts in gaining full adherence to the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) system showed great results.
For some background, Malaysia was made a provisional adherent to the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) system in 2008. The year 2010 saw the continued implementation of the OECD GLP framework, which is applicable to non-clinical health and environment safety studies. The Government then designated the National Pharmaceutical Control Bureau (NPCB) and Department of Standards Malaysia (Standards Malaysia) as the Compliance Monitoring Authority (CMAs) for Malaysia.
BiotechCorp has been working closely with the CMAs by organising programmes and capacity building initiatives for the CMAs and also the industry in order to ensure that Malaysia is fully ready for the On Site Evaluation and Mutual Joint Visit by the OECD inspectors in order to achieve full adherent status to the OECD MAD system.
In 2011, in preparation for the On Site Evaluation/ Mutual Joint Visit (OSE/MJV) by OECD, the following Compliance Programmes were conducted by the CMAs:
tOn 5-7 April 2011, both the CMAs attended the OECD Working Group (WG) Meeting to present to the OECD WG on Malaysia’s progress in the GLP Compliance Programme and our readiness for the MJV.
Based on the convincing progress made by Malaysia, the WG agreed that the MJV shall take place in November 2011
tOn 6-10 June 2011, BiotechCorp facilitated Standards Malaysia’s participation in an On Site Evaluation exercise by OECD inspectors to evaluate Greece as part of the run up to Malaysia’s inspection by OECD tOn 13-14 June 2011, BiotechCorp assisted the CMAs in the workshop
on Compliance of Computerised System to OECD-GLP held at Bayview Beach Resort in Penang
Issue / Activity Results
Pharma Regulations Intellectual Property (IP)
Pharmaceuticals are regulated by the National Pharmaceutical Control Bureau (NPCB) of the Ministry of Health under the Control of Drugs and Cosmetics Regulations 1984 which empowers the NPCB to implement the registration of:
a. Scheduled poisons/NCE/Biotechnology b. Non-scheduled poisons (over the counter) c. Traditional Medicines and Health Supplements d. Veterinary Products
e. Cosmetics (Registration of cosmetics was replaced by the Notification Procedure with effect from 1 January 2008.)
In 2011, the following directives / guidelines were issued and/or revised:
tDirective on Data Exclusivity (DE) (28 February 2011) t "4&"/-BCFMMJOH3FRVJSFNFOUT "QSJM
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In 2011, BiotechCorp completed work on its regulatory guidebook entitled
“EU and US Pharmaceutical Regulations: A Guide for Malaysian Companies”
XIJDI QSPWJEFT B VTFGVM PWFSWJFX PG UIF SFHVMBUPSZ SFRVJSFNFOUT GPS access into the EU and US markets. It also will enable Malaysian companies to better plan and implement appropriate regulatory strategies for successful product placement in those markets.
Throughout 2011, Malaysia continued to play an active role in harmonisation efforts through the ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplement Product
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A National Seminar on the Budapest Treaty was jointly organised by MyIPO in collaboration with the World Intellectual Property Organisation (WIPO) in September to create awareness among stakeholders on the workings and operations of the Budapest Treaty.
BiotechCorp remains engaged with MyIPO in its efforts for Malaysia to accede to the Budapest Treaty.
t $BQBDJUZ#VJMEJOH*OJUJBUJWFT
Various capacity building initiatives were also carried throughout the year including workshops and regulatory updates for internal and external customers.
Issue / Activity Results
In 2011, BiotechCorp participated in the Technical Working Group (TWG) for pharmaceutical, traditional medicines & health supplements and medical devices and provided industry input for the harmonisation of regulations in the three sectors in ASEAN. Through the ASEAN Consultative Committee in Safety and Quality (ACCSQ) Product Working Group (PWG) participation, we were able to keep track on the work programme progress and the time frame targeted in harmonising standards and reducing technical barriers towards a single market by 2015.
International Accreditation
(GLP) Pharma Regulations
In relation to GLP, Malaysia’s efforts in gaining full adherence to the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) system showed great results.
For some background, Malaysia was made a provisional adherent to the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) system in 2008. The year 2010 saw the continued implementation of the OECD GLP framework, which is applicable to non-clinical health and environment safety studies. The Government then designated the National Pharmaceutical Control Bureau (NPCB) and Department of Standards Malaysia (Standards Malaysia) as the Compliance Monitoring Authority (CMAs) for Malaysia.
BiotechCorp has been working closely with the CMAs by organising programmes and capacity building initiatives for the CMAs and also the industry in order to ensure that Malaysia is fully ready for the On Site Evaluation and Mutual Joint Visit by the OECD inspectors in order to achieve full adherent status to the OECD MAD system.
In 2011, in preparation for the On Site Evaluation/ Mutual Joint Visit (OSE/MJV) by OECD, the following Compliance Programmes were conducted by the CMAs:
tOn 5-7 April 2011, both the CMAs attended the OECD Working Group (WG) Meeting to present to the OECD WG on Malaysia’s progress in the GLP Compliance Programme and our readiness for the MJV.
Based on the convincing progress made by Malaysia, the WG agreed that the MJV shall take place in November 2011
tOn 6-10 June 2011, BiotechCorp facilitated Standards Malaysia’s participation in an On Site Evaluation exercise by OECD inspectors to evaluate Greece as part of the run up to Malaysia’s inspection by OECD tOn 13-14 June 2011, BiotechCorp assisted the CMAs in the workshop
on Compliance of Computerised System to OECD-GLP held at Bayview Beach Resort in Penang
Issue / Activity Results
Pharma Regulations Intellectual Property (IP)
Pharmaceuticals are regulated by the National Pharmaceutical Control Bureau (NPCB) of the Ministry of Health under the Control of Drugs and Cosmetics Regulations 1984 which empowers the NPCB to implement the registration of:
a. Scheduled poisons/NCE/Biotechnology b. Non-scheduled poisons (over the counter) c. Traditional Medicines and Health Supplements d. Veterinary Products
e. Cosmetics (Registration of cosmetics was replaced by the Notification Procedure with effect from 1 January 2008.)
In 2011, the following directives / guidelines were issued and/or revised:
tDirective on Data Exclusivity (DE) (28 February 2011) t "4&"/-BCFMMJOH3FRVJSFNFOUT "QSJM
t %SVH3FHJTUSBUJPO(VJEBODF%PDVNFOU %3(% 4FQUFNCFS t $MBTTJGJDBUJPOPG%FDJTJPO5SFF /PWFNCFS
In 2011, BiotechCorp completed work on its regulatory guidebook entitled
“EU and US Pharmaceutical Regulations: A Guide for Malaysian Companies”
XIJDI QSPWJEFT B VTFGVM PWFSWJFX PG UIF SFHVMBUPSZ SFRVJSFNFOUT GPS access into the EU and US markets. It also will enable Malaysian companies to better plan and implement appropriate regulatory strategies for successful product placement in those markets.
Throughout 2011, Malaysia continued to play an active role in harmonisation efforts through the ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplement Product
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Issue / Activity Results
Next Steps for Policy and Regulatory Engagement:
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Biosafety and Access and Benefit Sharing (ABS)
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Intellectual Property
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Pharma Regulations
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