The Pharma Journal

Pharmaceuticals and Medial Device Agency is the is the regulating Authority for Pharmaceuticals in Japan. This Agency came to force on 1/04/2014. The various registration Application are as follows: 1.Clinical Trial Notification for New drug development (IND). 2.New Drug Approval Application. 3.Generic Drug Approval Application. 4.Orphan Drug Application. 5.Priority review. 1. Clinical Trial Notification for New drug development (IND): Ø   This Application is important if the company intends to conduct clinical trial for a drug and to collect data for applying for manufacturing/marketing. Ø   The Clinical trial should be conducted as per Good Clinical Practice. Ø   If the Clinical trial is conducted for drugs with new APIs, Drugs with new route of administration, or if the drug is a new combination product, the clinical trial protocol has to be submitted. Ø   The review of application till takes 30 days after start of clinical trial. Ø   The ...

Introduction: The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.  It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.  The Declaration of Geneva of the World Medical Association binds the physician with the words, ‘‘The health of my patient will be my first consideration,’’ and the International Code of Medical Ethics declares that, ‘‘A physician shall act only in the patient’s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.’’ Medical progress is based on research which ultimately must rest in part on experiment...

 ICH Q9 guidelines are known as Quality Risk Management issued by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This guidelines gives description on how the Quality Risk Management can be applied to uphold the quality of medicines in Pharmaceutical Industry. This guideline also covers development, Manufacturing and Distribution including whole life cycle of medicinal products. Quality Risk Management can be defined as a systematic assessment of risks and a approach to control and communicate such risk to enhance Quality of product. Principle of Quality Risk Management: The principle includes Evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and the level of effort, formality and documentation of the quality risk management process should be in correspondence with the level of risk. Process of Quality Risk Management: The Quality Risk Management f...

 If you go back to 2018, Nitrosamines presence in the drug product were not known to the World. But since then, when  USFDA found the presence of Nitrosamines in the drug Products like Valsartan and Ranitidine, It became talk of the year in Pharma field.                            Nitrosamines are the class of compounds which are usually found in the meet. This compound is considered as cancer causing agent in a research conducted by International Agency for Research on Cancer( IARC). Nitrosamines are probable cancer causing agent to humans.It was first found by USFDA in a valsartan Active Pharmaceutical Ingredient(API) manufacturer from china.              The game started when, All the regulatory authorities like FDA, EMA, WHO,Health Singapore and even Indian CDSCO started to issue orders to the manufacturers to recall their products from the market and submit the product...

                                       The Covid-19 Pandemic has shattered the routine life of the world. All the countries are hit by this deadly pandemic.It has taken the life of millions of people across the world.Millions are falling sick. So on this worst time, its very important to maintain the health of us and our family members. I hereby list out few golden methods to stay fit and healthy. 1. Since social distancing has become new normal and mask has been made compulsory, its our utmost duty to follow these rules without fail. This will not only prevent us from getting Covid,but also saves our family and many more. ( Maintain at least 1 meter distance from others). 2. Use hand sanitizers ( preferably alcohol sanitizers) every 30 mins or so, before eating clean the hand and after coming from market, wash the hands atleast for 30 seconds.Dont give shake hands, instead, say nama...

1.WHO defends data after concluding Gilead's remdesivir flopped Covid-19 trial:- Gilead sciences Inc has questioned the findings that concluded remdesivir does not help patients who have been admitted to hospital, saying the "emerging (WHO) data appears inconsistent". Gilead was given data from the United Nations health agency's trial 10 days ago, to give it an opportunity to react. 2.  Zydus Cadila gets USFDA nod to market Fingolimod capsules, Verapamil Hydrochloride Injection:- Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Fingolimod capsules, (Gilenya) in the strengths of 0.5 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing. 3.  Chinese Covid-19 vaccine candidate shows promise in human trial: Study:- The latest study, published in The Lancet Infectious Diseases journal, included participants aged between 18 and 80 years and found that antibody responses were induced in a...