19 Jan 2017

MHRA UK: Registered drug database

Collection

Marketing authorisations: lists of granted licences

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs | RAPS

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs 


Posted 18 January 2017 By Zachary Brennan

A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.

More specifically, the US Food and Drug Administration (FDA) says the 37-page guidance offers recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs and whether they produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants.- See more at:

PHILIPPINES: DEPARTMENT OF HEALTH

REPUBLIC OF THE PHILIPPINES: DEPARTMENT OF HEALTH
http://www.doh.gov.ph/
Philippines Registered Drug database and drug price indicator both are integrated in a single well managed database by Department of Health of Republic of the Philippines.

Registered database provides the real time information and can be found on website search results with appropriate keywords. Database provides the following search results like: 


1. Acquisition Cost
2. Quantity
3. Brand Name
4. Manufacturer
5. Supplier


Drug search pattern is equivalent to the BNF of UK i.e. Drug Search by BNF Therapeutic Categories.

Pricing:
A good transparency has been maintained by the MoH, Philippines. The following type of Drug prices has been give on website

Drug Price Watch For Consumer
Drug Price Reference for Government
2015 Drug Price Reference Index Booklet

Drug Price Reference Index (DPRI) for all essential medicines to guide is published annually. Latest version in pdf format is valuable for the year 2016.
Also old edition of the same are available on the website like;

DPRI Booklet
a. Drug Price Reference 2016
b. Drug Price Reference 2015
c. Drug Price Reference 2013
d. Drug Price Reference 2012

What is the Drug Price Reference Index (DPRI)? The DPRI lists the ceiling prices of essential medicines for government bidding and procurement set by the DOH for all National and Local Government Health Facilities and Government Agencies. Winning bid prices of essential medicines within the DPRI ceiling reflect efficient and effective procurement in the government. Their transparencies and enforcement ensure consumer access to medicines and protection from excessive price mark-ups on medicines. The DPRI only reflects the acquisition costs including landed cost, packaging, drug content, quality assurance, manufacturing overheads and Food and Drug Administration (FDA) fees. The DPRI excludes other costs such as pharmacy services, preparation and storage fees, and other reasonable pharmacy mark-ups, which are now being evaluated by the DOH. The DPRI aims to improve the efficiency and good governance in the pricing and procurement of medicines in the public sector through establishing a transparent and publicly available reference price for affordable and quality medicines. It also aims to guide the Philippine Health Insurance Corporation (PHIC) in setting reimbursement caps for medicines both for inpatient and outpatient services. Who should use the DPRI? All government entities should be guided by the DPRI when procuring medicines. It shall be applied to all forms of procurement such as public bidding, direct contracting, shopping, negotiated procurement, emergency procurement and consignment to ensure that the government achieves the best value for money in sourcing essential medicines.

Disclaimer: All prices reflected are based on the lowest bidding procurement price conducted last 2015 of all DOH Hospitals. All manufacturers/suppliers included in this website are FDA registered and has a certificate of current Good Manufacturing Practice (cGMP) issued by the FDA.

Languages: English






China: Food and drug Administration

China Food and drug Administration

Chinese Portal

English portal

Chinese Registered Drug database are well managed by the China Food and drug Administration.

Registered database provides the real time information and can be found on website search results with appropriate keywords under clicking the “DATA SEARCH

There are many criteria under the drug search criteria like;

1. Domestic Drugs Database
2. Imported Drugs Database
3. Database of Drug Manufacturers in China
4. Database of GMP Certification
5. Database of approved Active Pharmaceutical Ingredients (APIs) and API manufacturers in China
6. Drug Manufacturing Certificate
7. Incomplete Lists of Vaccine Products

In database search can be done either basic and advanced. In advanced search many criteria are given by which search results can be found like;
  • Registration Certificate Number
  • Company Name (Chinese)
  • Company Name (English)
  • Product Name (Chinese)
  • Product Name (English)
  • Trade Name (Chinese)
  • Trade Name (English)
  • Manufacturer (Chinese)
  • Manufacturer (English)
  • Product Category
  • Drug Code




Also the results provides the detailed list of results of a particular product like;
  • · Registration Certificate Number
  • · The Original Registration Certificate Number
  • · Note of Registration Certificate Number
  • · Repackaging Approval Number
  • · Company Name (Chinese)
  • · Company Name (English)
  • · Address (Chinese)
  • · Address (English)
  • · Country/Region (Chinese)
  • · Country/Region (English)
  • · Product Name (Chinese)
  • · Product Name (English)
  • · Trade Name (Chinese)
  • · Trade Name (English)
  • · Dosage Form (Chinese)
  • · Strength (Chinese)
  • · Packaging Specification (Chinese)
  • · Manufacturer (Chinese)
  • · Manufacturer (English)
  • · Address of manufacturer (Chinese)
  • · Address of manufacturer (English)
  • · Country/Region of manufacturer (Chinese)
  • · Country/Region of manufacturer (English)
  • · Date of Issue
  • · Valid Until
  • · Name of Repackaging Enterprise
  • · Address of Repackaging Enterprise
  • · Approval Date of Repackaging Approval Number
  • · Repackaging Approval Number Valid Until
  • · Product Category
  • · Drug Code
  • Note of Drug Code
Pricing: not available.

Languages: English/ Chinese

17 Jan 2017

Myanmar: DRUG SAFETY NETWORK/ Pharmacovigilance App

Android and iphone App

DRUG SAFETY NETWORK

Drug Safety Network is an ADR reporting application for both android and ios users, conceived by Food and Drug Administration, Myanmar.

With the help of Drug Safety Network application, doctors can instantly report any suspected Adverse Drug Reaction to Food and Drug Administration, Myanmar.

iPhone App
Android App


Details:
This app is designed for both iPhone and iPad
Free
Category: Medical
Released: Jan 05, 2017
Version: 1.0
Size: 7.5 MB
Language: English
©2017 Food and Drug Administration, Myanmar

Compatibility: Requires iOS 7.0 or later. Compatible with iPhone, iPad, and iPod touch.