JP

 Approved Products
Regulations and Procedures
 Pharmacopoeia
Medical Device Standards
  • What's NewBack number
->September 28, 2012 Update
PMDA Updates (September, 2012) posted
->September 25, 2012 Update
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA updated
->September 25, 2012 New
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 293, 2012
->September 11, 2012
Safety information announced by MHLW: Alert for the risk of severe hypocalcemia in patients who take RANMARK® (denosumab)
->September 11, 2012
Dear Healthcare Professional Letter of Rapid Safety Communication: RANMARK (denosumab) – Risk of severe hypocalcaemia, including fatal cases
->September 7, 2012
PMDA Medical Safety Information
->September 6, 2012
Basic Principles on Global Clinical Trials (Reference cases) posted
->August 31, 2012
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA (Cibenzoline, lithium carbonate, Telaprevir, Levocabastine, Diclofenac, Tocilizumab, Tetracosactide, Propylthiouracil, Tegafur/ Gimeracil/ Oteracil Potassium) posted
->August 30, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 293, 2012
->August 29, 2012
English translations of Ministerial Ordinances on Good Laboratory Practice for Nonclinical Safety Stuides of Drugs/Medical Devices
->August 29, 2012
English translations of Notifications on Implementation of Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Stuides of Drugs/Medical Devices
->August 29, 2012
New drug approvals: April – June 2012
->August 29, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 292, 2012
->August 28, 2012
Medical device approvals FY 2011: New medical devices and improved medical devices (with clinical data)
->August 27, 2012
PMDA Updates (August, 2012) posted
->August 3, 2012
The outcomes of the second Science Board Meeting
->Aug. 1, 2012
PDG Stage 4 drafts for Petrolatum, White Petrolatum and Isomalt are uploaded.
->July 31, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 292, 2012
->July 30, 2012
Placement of a liaison official has boosted interaction with EMA
->July 27, 2012
The PMDA convenes the second Science Board meeting
->July 25, 2012
English translation of review report: Rapiacta
->July 25, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 291, 2012
->July 25, 2012
PMDA Updates (July, 2012) posted
->July 20, 2012
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA (Ropinirole, Varenicline, Suxamethonium, Diazoxide, Pamidronate, Zoledronic Acid, Oxaliplatin, Nelarabine) posted
->July 4, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 291, 2012
->June 22, 2012
The outcomes of the first Science Board Meeting
->June 22, 2012
PMDA convenes inaugural Science Board meeting – enhancing the review system responding to the Medical Innovations –
->June 22, 2012
PMDA Updates (June, 2012) posted
->June 20, 2012
Pharmacopoeial Discussion Group (PDG) Meeting (Tokyo, June 5-6, 2012) Press Release posted
->June 20, 2012
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA (Pregabalin, Metformin, Methotrexate, Nilotinib,Temsirolimus, Voriconazole, Sitafloxacin, Ciprofloxacin, Famciclovir, Adefovir, Pneumococcal Vaccine, Influenza HA Vaccine) posted
->June 7, 2012
English translation of review report: Victoza
->June 7, 2012
PMDA Risk Communication: New Important Information on the use of Telavic® Tablet (telaprevir) and a potetial risk of severe renal impairment including acute renal failure updated
->June 6, 2012
PMDA request for proper use of drugs: No.9 Early Detection of Drug-induced Serious Skin Disorders
->June 4, 2012
New drug approvals: Fiscal year 2011(April 2011 – March 2012)
New medical device approvals: April – December 2011
->May 31, 2012
English translation of Administrative Notice: On the Standard Review Timeline for New Drug Applications
->May 30, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 290, 2012
->May 28, 2012
PMDA request for proper use of drugs : No 8: Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group
->May 28, 2012
PMDA Updates (May, 2012) posted
->May 23, 2012
Safety Information announced by MHLW: Risk Management Plan Guidance posted
->May 16, 2012
PMDA Risk Communication: Alert for the use of RANMARK® (Denosumab) and a risk of severe hypocalcaemia
->May 14, 2012
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA (Escitalopram, Trazodone, Azosemide, Hydralazine, Eltrombopag, Garenoxacin, Darunavir, Telaprevir, Ivermectin) posted
->May 11, 2012
PMDA Medical Safety Information
->May 10, 2012
PMDA Risk Communication: New Important Information on the use of TELAVIC® Tablet (telaprevir) and a potential risk of severe renal impairment including acute renal failure posted
->May 9, 2012
Administrative Notice: English translations of the Guidance for Establishing Safety in First-in-Human Studies during Drug Development and its Questions and Answers
->May 8, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 290, 2012
->May 1, 2012
PMDA request for proper use of drugs : No 7 Lithium Carbonate-induced Serious Lithium Poisoning and Compliance with Measurement of Blood Lithium Level posted
->April 27, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 289, 2012
->April 27, 2012
A delegation from Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom visited PMDA for the first Japan- UK bilateral meeting.
->April 20, 2012
PMDA Updates (April, 2012) posted
->April 9, 2012
PMDA Risk Communications: Drug Risk Information of Ongoing Evaluation dated April 6, 2012 updated
Services of PMDA
Drug and Medical Device Reviews
Scientific reviews and conformity audits of marketing authorization applications of drugs and medical devices, clinical trial consultations
Post-marketing Safety
Collection, analysis and dissemination of information related to the quality, efficacy and safety of pharmaceuticals and medical devices
Relief Services for Adverse Health Effects
Providing financial assistance for individuals affected by adverse drug reactions or infections from biological products
International Programs
Implementation of PMDA International Strategic Plan through international regulatory harmonization, bilateral relationship, effective communication with relevant external parties, etc.
  • News and Reports
  • Past Events / Symposia
  • Past Presentations
  • Publications
  • FAQ

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s