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Text of the page (random words):
ation products cosmetic products generic medicines natural products health supplement new chemical entity nce veterinary medicine regulatory information basic regulation active pharmaceutical ingredients api bioequivalence and ethics committee inspection compliance and licensing good clinical practice gcp good laboratory practice glp laboratory quality control medicinal gases pharmacovigilance phase i unit inspection accreditation programme surveillance complaints more regulations industry main page drug registration guidance documents drgd helpdesk enquiry in house application market sampling quest updates and announcements medicine shortage discontinuation reporting recent updates consumers reporting reporting on notified cosmetic products reporting side effects to medicines conserf or vaccines aefi quality reporting on registered product consumer information consumer main page products search technical evaluation summary e brochures vaccine lot release lot release certificate plasma products lot release lot release certificate online public engagement contact us lot release for covid 19 vaccines safety information cancellation of registered complementary alternative product cancellation of notified cosmetic products adulterated products unregistered vaccine lot release notification of non compliance plasma products lot release notification of non compliance product recall health professionals health professionals main page safety alerts direct healthcare professional communications dhpcs medsafetyweek reporting adr aefi quality reporting madrac bulletin reaksi drug safety news press releases on aefis of covid 19 vaccines summary reports on aefis of covid 19 vaccines information general information announcement press release circulars directives training seminars research development e labelling new products indication new products approved additional indications approved new chemical entities biosimilars approved surface disinfectants approved orphan medicines approved quest list of manufacturers wholesalers importers quest 3 license search list of cosmetic manufacturers in quest system annual reports npra annual reports national centre for adverse drug reaction monitoring annual report safety information cancellation of registered complementary alternative product cancellation of notified cosmetic products adulterated products unregistered vaccine lot release notification of non compliance plasma products lot release notification of non compliance product recall newsletter berita ubat ubatan e brochures coffee table book about npra npra information vision mission and objective roles and functions organisation chart npra s clients charter npra s quality objective npra obligation npra quality policy ms iso 9001 2015 certification scope eksa bulletin npra safety policy gallery online public engagement tawaran iklan recognition international membership who collaborating centre pic s oecd glp mad npra awards recognition useful links staff directory our location contact us drug control authority dca dca members about the dca dca expert advisor panel dca news malaysian adverse drug reactions advisory committee madrac madrac introduction madrac members national pharmaceutical regulatory agency npra lot 36 jalan universiti jalan prof diraja ungku aziz 46200 petaling jaya selangor malaysia phone 603 7883 5400 industry quest3 system main page qclab800x400mm png banner trustid id png images 2026 banner desktop_banner jpg images 2026 banner dcc png images 2026 banner banner industry prp poster 126 png images 2026 banner pengemaskinian_borang png click here images 2026 banner login_mobile png images 2026 banner adr aefi google form industry banner 800 x 400 px png click here images 2026 banner annexes_1750400 png click here images 2026 banner gangguan_800 x 400 png web direktif dirguideline images 2026 banner drgd_800x400 png more images 2026 banner kaji_2 png images 2026 banner madrac vol_61_800 x 400 px png more images 2026 banner banner industry prp poster 08092026 png images 2026 banner lren_2027__1000_x_560_px_final_25092026 jpg images 2026 banner reliance banner 800x400 v2 jpg npra on battling covid 19 and updates during conditional movement control order cmco notification exemption quest configuration technical evaluation summary certificate licence collection centre medicine shortage discontinuation reporting recent updates products containing turmeric and curcuminoids risk of hepatotoxicity published on 2026 10 06 biosimilar approved published on 2026 09 28 guideline on application of manufacturer s license import license and wholesaler s license for registered products 5th edition september 2026 published on 2026 09 25 direktif pelaksanaan dan pengendalian label keselamatan published on 2026 09 18 list of renewal approved veterinary products published on 2026 09 08 view more recent updates calendar activities no events view full calendar regulatory information product classification quest3 system basic asean guidance documents guideline for the submission of product samples for laboratory testing clinical trials regulation basic among the pharmacovigilance activities carried out by npra are adverse drug reaction adr monitoring and screening of drug safety alerts these activities allow identification of drug safety issues which are reviewed in order to implement preventative measures npra also communicates information on drug safety issues to healthcare professionals and the public in our ongoing effort increase patient safety pharmacovigilance the submission of sample for laboratory testing is as part of the registration process this guideline consists of the general and specific requirements for the submission of samples to the centre for quality control for laboratory testing the general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product laboratory quality control any matters related to inspection of bioequivalence be centres listing of ethics committee ec with drug control authority dca bioequivalence centre ethics committee good laboratory practice glp is a quality system concerned with the organisational process and the conditions under which non clinical health and environment safety studies are planned performed monitored recorded archived and reported the purpose of the principles of glp is to promote the development of quality data good laboratory practice glp any company that want to manufacture import or wholesale any registered products need to have manufacturer s license import license or wholesale license licensing certification section is involved in the activity of issuance of license compliance licencing a significant part of the quality of a finished product is dependent on the quality of the active pharmaceutical ingredients apis used for its formulation thus a proper system of qualification of suppliers is necessary to ensure a constant sourcing of apis of appropriate quality and to safeguard the public health interests this will be done through standardized quality assessment and inspection procedures active pharmaceutical ingredients apis medicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic therapeutic prophylactic and diagnostic use medicinal gases product categories browse guidelines directives circulars announcements and application forms according to product categories cosmetics any preparation intended to be placed in contact with various external parts of the human body natural products traditional general traditional medium generic medicines bioequivalence be prescription full non prescription full abridge biologics biological biotech biosimilar vaccines blood products others new chemical entity new chemical entity radiopharmaceutical substances new combination products supplemental products health supplements general functional medium disease risk reduction high veterinary medicines scheduled poison non poison innovator nce combination products drug medical device and medical device drug combination products national pharmaceutical regulatory agency npra lot 36 jalan universiti jalan prof diraja ungku aziz 46200 petaling jaya selangor malaysia phone 603 7883 5400 more links our location public enquiry privacy policy archives more links our location public enquiry privacy policy security policy archives sitemap npra staff mygovernment portal disclaimer the government of malaysia and the national pharmaceutical regulatory agency are not responsible for any loss or damage caused by the usage of any information obtained from this website daily popup by yannicktanguy com site last modified last modified friday 09 october 2026 14 27 37 online services quest3 system npra support system online public engagement online procurement announcement copyright 2024 all rights reserved national pharmaceutical regulatory agency npra site map npra product status search main menu english home industry product categories biologic combination products cosmetic products generic medicines natural products health supplement new chemical entity nce veterinary medicine regulatory information basic regulation active pharmaceutical ingredients api bioequivalence and ethics committee inspection compliance and licensing good clinical practice gcp good laboratory practice glp laboratory quality control medicinal gases pharmacovigilance phase i unit inspection accreditation programme surveillance complaints more regulations industry main page drug registration guidance documents drgd helpdesk enquiry in house application market sampling quest updates and announcements medicine shortage discontinuation reporting recent updates consumers reporting reporting on notified cosmetic products reporting side effects to medicines conserf or vaccines aefi quality reporting on registered product safety information cancellation of registered complementary alternative product cancellation of notified cosmetic products adulterated products unregistered vaccine lot release notification of non compliance plasma products lot release notification of non compliance product recall consumer information consumer main page products search technical evaluation summary e brochures vaccine lot release lot release certificate plasma products lot release lot release certificate online public engagement contact us lot release for covid 19 vaccines health professionals health professionals main page safety alerts direct healthcare professional communications dhpcs medsafetyweek reporting adr aefi quality reporting madrac bulletin reaksi drug safety news press releases on aefis of covid 19 vaccines summary reports on aefis of covid 19 vaccines information general information announcement press release circulars directives training seminars research development e labelling new products indication new products approved additional indications approved new chemical entities biosimilars approved surface disinfectants approved orphan medicines approved quest list of manufacturers wholesalers importers quest 3 license search list of cosmetic manufacturers in quest system annual reports npra annual reports national centre for adverse drug reaction monitoring annual report newsletter berita ubat ubatan e brochures coffee table book covid 19 information covid 19 information page safety information cancellation of registered complementary alternative product cancellation of notified cosmetic products adulterated products unregistered vaccine lot release notification of non compliance plasma products lot release notification of non compliance product recall about npra npra information vision mission and objective roles and functions organisation chart npra s clients charter npra s quality objective npra obligation npra quality policy ms iso 9001 2015 certification scope eksa bulletin npra safety policy gallery online public engagement tawaran iklan recognition international membership who collaborating centre pic s oecd glp mad npra awards recognition drug control authority dca dca members about the dca dca expert advisor panel dca news malaysian adverse drug reactions advisory committee madrac madrac introduction madrac members useful links staff directory our location contact us choose your language bahasa melayu english uk home friday 9 oct 2026 industry menu home industry product categories biologic combination products cosmetic products generic medicines natural products health supplement new chemical entity nce veterinary medicine regulatory information basic regulation active pharmaceutical ingredients api bioequivalence and ethics committee inspection compliance and licensing good clinical practice gcp good laboratory practice glp laboratory quality control medicinal gases pharmacovigilance phase i unit inspection accreditation programme surveillance complaints more regulations industry main page drug registration guidance documents drgd helpdesk enquiry in house application market sampling quest updates and announcements medicine shortage discontinuation reporting recent updates consumers reporting reporting on notified cosmetic products reporting side effects to medicines conserf or vaccines aefi quality reporting on registered product safety information cancellation of registered complementary alternative product cancellation of notified cosmetic products adulterated products unregistered vaccine lot release notification of non compliance plasma products lot release notification of non compliance product recall consumer information consumer main page products search technical evaluation summary e brochures vaccine lot release lot release certificate plasma products lot release lot release certificate online public engagement contact us lot release for covid 19 vaccines health professionals health professionals main page safety alerts direct healthcare professional communications dhpcs medsafetyweek reporting adr aefi quality reporting madrac bulletin reaksi drug safety news press releases on aefis of covid 19 vaccines summary reports on aefis of covid 19 vaccines information general information announcement press release circulars directives training seminars research development e labelling new products indication new products approved additional indications approved new chemical entities biosimilars approved surface disinfectants approved orphan medicines approved quest list of manufacturers wholesalers importers quest 3 license search list of cosmetic manufacturers in quest system annual reports npra annual reports national centre for adverse drug reaction monitoring annual report newsletter berita ubat ubatan e brochures coffee table book covid 19 information covid 19 information page safety information cancellation of registered complementary alternative product cancellation of notified cosmetic products adulterated products unregistered vaccin...