Dos and Don’ts in a regulatory consultation meeting
The next step after performing a regulatory intelligence exercise would be followed by an arrangement for a consultation with the regulatory authority. This is common especially for IND application and NDA application in which there may be concerns regarding the documentation requirements or even addressing any critical CMC, pre-clinical and clinical study related questions. Today […]
Steps to incorporate new regulation changes in approved marketing authorization (MAs)
Part of our routine activity in regulatory affairs is to stay in touch with the latest updates and happenings with our local authority so that we can interpret the new changes, assess the impact it has on our existing product licenses and implement a strategic plan to incorporate the changes. Today TRC would like […]
Should you consider a regulatory subscription plan or adopt a traditional model of hiring your regulatory staff?
A regulatory subscription plan is a newly launched product created by TRC to support medical companies in need of regulatory assistance in a new territory where there is no local office established /when there are only requirement to support post-licensing activities / when additional or alternative support will come in handy when getting the right […]
What is a borderline medical device in ASEAN terms and published list for your reference?
This is a rather short article to share about the definition and published list of borderline medical device that might be supportive for your regulatory intelligence exercise. A borderline medical device might have some features of a medical device which is to diagnose ,treat or prevent a symptoms or diseases and possibly contain agent or […]
3 facts to know when importing cosmetics into Singapore
Cosmetics are required to be notified before they can be sold in the market unless in the few circumstances below: Supplied solely as a sample in connection with any advertising, sponsorship or promotional activity Supplied solely for testing or trial use in connection with any research or development of that product Manufactured by or in […]
Key things to note when importing Health Supplements into Singapore
At the current moment, Health Supplements are not subjected to registration prior to importation. Notification is on a voluntary basis. There may be advantage for you to execute the notification of the health supplements from a commercial perspective and it is always to be pro-active to adapt to the existing regulations rather than to rush […]